FDA Device recall Z-1163-2016
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
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX… by Zimmer Manufacturing B V, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1163-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Manufacturing B V |
| Distribution | US |
Product
Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006 VERSA-FX II KEYLESS TUBE 119413008 VERSA-FX II KEYLESS TUBE 119413504 VERSA-FX II KEYLESS TUBE 119413505 VERSA-FX II KEYLESS TUBE 119413506 VERSA-FX II KEYLESS TUBE 119413508 VERSA-FX II KEYLESS TUBE 119414004 VERSA-FX II KEYLESS TUBE 119414005 VERSA-FX II KEYLESS TUBE 119414006 VERSA-FX II KEYLESS TUBE 119414008 VERSA-FX II KEYLESS TUBE 119414504 VERSA-FX II KEYLESS TUBE 119414506 VERSA-FX II KEYLESS TUBE 119414508 VERSA-FX II KEYLESS TUBE 119415004 VERSA-FX II KEYLESS TUBE 119415005 VERSA-FX II KEYLESS TUBE 119415006 VERSA-FX II KEYLESS TUBE 119415008 VERSA-FX II KEYLESS TUBE 119313094 VERSA-FX II SHORT TUBE PL 119313095 VERSA-FX II SHORT TUBE PL 119313096 VERSA-FX II SHORT TUBE PL 119313594 VERSA-FX II SHORT TUBE PL 119313595 VERSA-FX II SHORT TUBE PL 119313596 VERSA-FX II SHORT TUBE PL 119314094 VERSA-FX II SHORT TUBE PL 119314594 VERSA-FX II SHORT TUBE PL 119314595 VERSA-FX II SHORT TUBE PL 119315094 VERSA-FX II SHORT TUBE PL 119315095 VERSA-FX II SHORT TUBE PL 119313002 VERSA-FX II STD TUBE PLAT 119313003 VERSA-FX II STD TUBE PLAT 119313004 VERSA-FX II STD TUBE PLAT 119313005 VERSA-FX II STD TUBE PLAT 119313006 VERSA-FX II STD TUBE PLAT 119313008 VERSA-FX II STD TUBE PLAT 119313010 VERSA-FX II STD TUBE PLAT 119313012 VERSA-FX II STD TUBE PLAT 119313502 VERSA-FX II STD TUBE PLAT 119313503 VERSA-FX II STD TUBE PLAT 119313504 VERSA-FX II STD TUBE PLAT 119313505 VERSA-FX II STD TUBE PLAT 119313506 VERSA-FX II STD TUBE PLAT 119313508 VERSA-FX II STD TUBE PLAT 119313510 VERSA-FX II STD TUBE PLAT 119313512 VERSA-FX II STD TUBE PLAT 119314002 VERSA-FX II STD TUBE PLAT 119314003 VERSA-FX II STD TUBE PLAT 119314004 VERSA-FX II STD TUBE PLAT 119314005 VERSA-FX II STD TUBE PLAT 119314006 VERSA-FX II STD TUBE PLAT 119314502 VERSA-FX II STD TUBE PLAT 119314503 VERSA-FX II STD TUBE PLAT 119314504 VERSA-FX II STD TUBE PLAT 119314505 VERSA-FX II STD TUBE PLAT 119314506 VERSA-FX II STD TUBE PLAT 119314510 VERSA-FX II STD TUBE PLAT 119314512 VERSA-FX II STD TUBE PLAT 119315003 VERSA-FX II STD TUBE PLAT 119315004 VERSA-FX II STD TUBE PLAT 119315005 VERSA-FX II STD TUBE PLAT 119315006 VERSA-FX II STD TUBE PLAT 119315012 VERSA-FX II STD TUBE PLAT 119315014 VERSA-FX II STD TUBE PLAT 119315018 VERSA-FX II STD TUBE PLAT 119309008 VERSA-FX II SUPRACONDYLR 119309010 VERSA-FX II SUPRACONDYLR 119309012 VERSA-FX II SUPRACONDYLR 119309014 VERSA-FX II SUPRACONDYLR 119309506 VERSA-FX II SUPRACONDYLR 119309508 VERSA-FX II SUPRACONDYLR 119309510 VERSA-FX II SUPRACONDYLR 119309512 VERSA-FX II SUPRACONDYLR 119309514 VERSA-FX II SUPRACONDYLR 119309516 VERSA-FX II SUPRACONDYLR 119309522 VERSA-FX II SUPRACONDYLR Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
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.
Identifiers
| code_info | lot no.: 61672127 61762385 61804344 61866511 61896678 61940978 61952481 62271940 61906562 61909135 61909415…lot no.: 61672127 61762385 61804344 61866511 61896678 61940978 61952481 62271940 61906562 61909135 61909415 61708338 61758144 61861311 61879904 61952217 61953206 62130792 62230218 61957579 61762384 61884793 61955865 61866504 61758145 61804342 61866505 61866507 61896676 61896677 61940979 61952464 61952470 61953207 61955866 61957580 62124267 62124268 62124270 62124271 62130789 62130790 62241717 62310746 62310749 61758148 61861312 61952480 62230213 370683 61849236 61866510 61955864 62130791 62271939 370686 61758149 61925936 61640891 61714083 61804347 61884794 62127926 62230216 62271941 371037 61915562 370921 371035 37107414 61901766 62230196 61920050 61708350 370684 371070 61866503 61901767 61920919 62271937 371073 370622 62105420 370541 61828070 61808819 61843710 62016616 62103684 62136373 62141977 61835223 62136374 61839354 61672109 61753030 61753032 61753034 61824698 61844439 61867392 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1163-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.