FDA Device recall Z-1114-2016
Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LI…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LI… 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-1114-2016 |
| 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 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 500104428 BIPOLAR LINER 44/45/46MM 500104422 BIPOLAR LINER 44MM OD X 2 500104426 BIPOLAR LINER 44MM OD X 2 500104728 BIPOLAR LINER 47/48/49MM 500104722 BIPOLAR LINER 47MM OD X 2 500104726 BIPOLAR LINER 47MM OD X 2 500104732 BIPOLAR LINER 47MM OD X 3 500105028 BIPOLAR LINER 50/51/52MM 500105022 BIPOLAR LINER 50MM OD X 2 500105026 BIPOLAR LINER 50MM OD X 2 500105328 BIPOLAR LINER 53/54/55MM 500105322 BIPOLAR LINER 53MM OD X 2 500105326 BIPOLAR LINER 53MM OD X 2 500105728 BIPOLAR LINER 57/58MM OD 500105722 BIPOLAR LINER 57MM OD X 2 500106028 BIPOLAR LINER 60/62MM OD 500106828 BIPOLAR LINER 68/70MM OD 500106832 BIPOLAR LINER 68MM OD X 3 500107228 BIPOLAR LINER 72MM OD X 2 500103800 BIPOLAR SHELL 38MM OD 500103900 BIPOLAR SHELL 39MM OD 500104000 BIPOLAR SHELL 40MM OD 500104100 BIPOLAR SHELL 41MM OD 500104200 BIPOLAR SHELL 42MM OD 500104300 BIPOLAR SHELL 43MM OD 500104400 BIPOLAR SHELL 44MM OD 500104500 BIPOLAR SHELL 45MM OD 500104600 BIPOLAR SHELL 46MM OD 500104700 BIPOLAR SHELL 47MM OD 500104800 BIPOLAR SHELL 48MM OD 500104900 BIPOLAR SHELL 49MM OD 500105000 BIPOLAR SHELL 50MM OD 500105100 BIPOLAR SHELL 51MM OD 500105200 BIPOLAR SHELL 52MM OD 500105300 BIPOLAR SHELL 53MM OD 500105400 BIPOLAR SHELL 54MM OD 500105500 BIPOLAR SHELL 55MM OD 500105700 BIPOLAR SHELL 57MM OD 500105800 BIPOLAR SHELL 58MM OD 500106000 BIPOLAR SHELL 60MM OD 500106200 BIPOLAR SHELL 62MM OD 500107000 BIPOLAR SHELL 70MM OD Product Usage: For use in total or hemi hip arthroplasty
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.: 62219247 62363097 62363094 62389670 61875674 61925649 62033251 62170686 62175401 62183232 62194621…lot no.: 62219247 62363097 62363094 62389670 61875674 61925649 62033251 62170686 62175401 62183232 62194621 62204619 62204620 62210652 62215055 62215056 62216739 62226849 62226850 62238102 62238103 62250451 62261990 62261991 62268511 62321738 62338907 62338908 62354772 62363091 62378265 62378266 62384300 62389419 62389656 62389657 62389658 62389659 62389660 62396113 62402107 62402108 62402110 62188390 62215057 62247753 62340246 62389667 61839824 61875682 61884434 61902089 61902090 61939396 61941049 61980218 62188391 62188392 62194622 62195533 62207261 62207262 62208774 62208775 62208777 62210653 62210654 62210655 62210656 62216730 62216731 62216732 62222892 62226851 62226853 62226854 62232603 62232604 62234540 62234542 62238104 62238105 62239378 62240421 62240422 62240424 62250452 62250453 62250454 62250464 62250465 62266485 62266486 62268512 62268513 62268524 62283118 62285312 62293255 |
|---|
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-1114-2016%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.