FDA Device recall Z-1149-2016
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OP…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OP… 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-1149-2016 |
| 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 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 598605702 NEXGEN OPTION STEMMED TIB for use in total knee 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.: 61627858 61667594 61687053 61687057 61711627 61711636 61711638 61711640 61711642 61787558 61787559…lot no.: 61627858 61667594 61687053 61687057 61711627 61711636 61711638 61711640 61711642 61787558 61787559 61787560 61787561 61787562 61791460 61791462 61791464 61791466 61791467 61791468 61797925 61797926 61797927 61797928 61797929 61797930 61797931 61797932 61797933 61809215 61809216 61809217 61809218 61809219 61816553 61820496 61820497 61820498 61823244 61823245 61823246 61823247 61823248 61829314 61829315 61829316 61829317 61829318 61838186 61838187 61838188 61838189 61838190 61850512 61850513 61850515 61850516 61850517 61861391 61861392 61861393 61861394 61861395 61865095 61865096 61865097 61865098 61870089 61870090 61870091 61870092 61875986 61875987 61875988 61875989 61875990 61879452 61879453 61879454 61890348 61890349 61890350 61890351 61890352 61890353 61898708 61898709 61898710 61898711 61907203 61907204 61907206 61907207 61907208 61907210 61919431 61919432 61919437 61919439 |
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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-1149-2016%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.