FDA Device recall Z-1166-2016
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
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CE… 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-1166-2016 |
| 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 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 787101561 VERSYS CEM/REV/CALCAR 15X 787101562 VERSYS CEM/REV/CALCAR 15X 787101563 VERSYS CEM/REV/CALCAR 15X 787101760 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X 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.: 61750613 61750614 61868570 61952541 62024610 62030924 62038337 62042578 62050967 62050968 62055953…lot no.: 61750613 61750614 61868570 61952541 62024610 62030924 62038337 62042578 62050967 62050968 62055953 62058544 62062916 62067900 62076933 62079992 62086045 62097029 62112166 62114833 62132264 62134027 62134028 62143844 62143845 62159824 62199401 62199402 62202245 62222764 62225719 62236534 62240268 62240781 62240783 62244343 62244344 62256020 62256021 62256022 62264272 62270718 62277491 62277507 62277508 62305949 62305950 62312493 62312494 62315892 62318764 62320156 62325567 62326096 62332923 62332924 62332925 62340037 62340038 61843322 61856105 61864096 61868571 62042579 62055955 62055956 62076934 62076936 62086043 62112165 62114834 62132263 62143842 62197213 62199403 62207226 62244341 62244342 62256025 62257216 62266494 62268559 62279449 62287353 62291944 62298295 62299092 62305947 62317922 62326097 62340039 62340040 62005387 62024613 62069014 62097031 62134029 62192539 62202246 |
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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-1166-2016%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.