Stryker Howmedica Osteonics recalls
Stryker Howmedica Osteonics appears in 87 official U.S. recall notices indexed by RecallRadar, most recently on 2017-05-31.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 87 |
|---|---|
| Published | 2012-06-27 to 2017-05-31 |
| By agency | FDA Device (87) |
| By classification | Class II (86), Class I (1) |
| By status | terminated (85), ongoing (2) |
| Distribution named in notices | CA, DE, GA, IL, KY, MA, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SC, TN, US, UT, VA, WI, WV |
Recalls
- Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended f…
FDA Device · Class II · 2017-05-31 · Stryker Howmedica Osteonics
Reason: Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mech… - Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion…
FDA Device · Class II · 2017-01-18 · Stryker Howmedica Osteonics
Reason: Reunion TSA Peg Alignment Sound broke during surgery. - GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Ge…
FDA Device · Class II · 2016-12-28 · Stryker Howmedica Osteonics
Reason: A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error. - LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236
FDA Device · Class II · 2016-11-16 · Stryker Howmedica Osteonics
Reason: Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads. - Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA,…
FDA Device · Class II · 2016-10-19 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner. - Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal so…
FDA Device · Class II · 2016-09-21 · Stryker Howmedica Osteonics
Reason: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. - Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Ins…
FDA Device · Class II · 2016-09-21 · Stryker Howmedica Osteonics
Reason: Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument. - Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either a…
FDA Device · Class II · 2016-09-21 · Stryker Howmedica Osteonics
Reason: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. - Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system
FDA Device · Class II · 2016-08-17 · Stryker Howmedica Osteonics
Reason: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. - Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reu…
FDA Device · Class II · 2016-08-17 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potent… - Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standa…
FDA Device · Class II · 2016-08-17 · Stryker Howmedica Osteonics
Reason: It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further invest… - Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm
FDA Device · Class II · 2016-08-03 · Stryker Howmedica Osteonics
Reason: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. - VariAx Compression Plating System
FDA Device · Class II · 2016-04-27 · Stryker Howmedica Osteonics
Reason: Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole. - Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker Vitallium Wire (6 Pack) Non Sterile
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU st… - Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. - Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile
FDA Device · Class II · 2015-12-09 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s). - Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthro…
FDA Device · Class II · 2015-11-25 · Stryker Howmedica Osteonics
Reason: Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612. - Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component
FDA Device · Class II · 2015-11-18 · Stryker Howmedica Osteonics
Reason: Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. - Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon M…
FDA Device · Class II · 2015-11-18 · Stryker Howmedica Osteonics
Reason: Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use. - Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
FDA Device · Class II · 2015-09-30 · Stryker Howmedica Osteonics
Reason: it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field. - rHead Lateral Stem, Size 1, Do Not Reuse, Sterile
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics
Reason: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. - Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics
Reason: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. - uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics
Reason: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. - Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics
Reason: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. - Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics
Reason: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. - Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to…
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics
Reason: Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209). - Triathlon PS X3 Tibial Insert
FDA Device · Class II · 2015-08-19 · Stryker Howmedica Osteonics
Reason: Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert. - ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818
FDA Device · Class II · 2015-08-19 · Stryker Howmedica Osteonics
Reason: A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial. - Stryker Orthopaedics Triathlon femoral component
FDA Device · Class II · 2015-05-27 · Stryker Howmedica Osteonics
Reason: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier. - Stryker Howmedica Osteonics RESTORATION Acetabular Augment System
FDA Device · Class II · 2015-05-27 · Stryker Howmedica Osteonics
Reason: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier. - Stryker Orthopaedics Scorpio femoral component
FDA Device · Class II · 2015-05-27 · Stryker Howmedica Osteonics
Reason: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier. - Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial basep…
FDA Device · Class II · 2015-05-20 · Stryker Howmedica Osteonics
Reason: Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm. - Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a captu…
FDA Device · Class II · 2015-03-25 · Stryker Howmedica Osteonics
Reason: Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.