FDA Device recall Z-1165-2016
Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADV…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADV… 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-1165-2016 |
| 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 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE 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.: 62012574 62076883 62082566 61866199 61874734 61893708 61899069 62022707 62028699 62030919 62042521…lot no.: 62012574 62076883 62082566 61866199 61874734 61893708 61899069 62022707 62028699 62030919 62042521 62051543 62060669 62075336 62079977 62079978 62079980 62113214 62114829 62114830 62122093 62128919 62128920 62132260 62140346 62148554 62160578 62163478 62188294 62222803 62222804 62223792 62240251 62240759 62240760 62246361 62246362 62246363 62258940 62260127 62261929 62261930 62284475 62284476 62314462 62317914 62320163 62327664 62330771 62331423 62340088 62354662 62354663 62360329 61823659 61832951 61866206 61866208 61873629 61881191 61886904 61889280 61890330 61891276 61896738 61901567 61901568 61952538 61953162 62010628 62027792 62028704 62028706 62028707 62035446 62042575 62050380 62051541 62051542 62058542 62060667 62060668 62079983 62079984 62097006 62097008 62103562 62103563 62103564 62122094 62122095 62122096 62125316 62127721 62127722 62128921 62128922 62132261 62132262 |
|---|
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-1165-2016%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.