Zimmer Manufacturing B V recalls
Zimmer Manufacturing B V appears in 91 official U.S. recall notices indexed by RecallRadar, most recently on 2016-05-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 91 |
|---|---|
| Published | 2014-07-16 to 2016-05-25 |
| By agency | FDA Device (91) |
| By classification | Class II (91) |
| By status | terminated (91) |
| Distribution named in notices | AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, US, UT, VA, WI |
Recalls
- VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini M…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabul…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. - Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile
FDA Device · Class II · 2016-04-13 · Zimmer Manufacturing B V
Reason: The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side s… - Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty
FDA Device · Class II · 2016-04-13 · Zimmer Manufacturing B V
Reason: The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side s… - Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total kne…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN A…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KN…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL D…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthr…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY A…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X2…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A sm…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MI…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCRE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in t…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR C…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRES…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN P…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL ME…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi h…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIP…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCRE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. - Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V
Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.