NexGen Offset Stem Extension — Class II medical device recall Z-2115-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-05-24, distributed in CA, HI, IN, MN, NJ, PA, VA, WA…. Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem
| Recall number | Z-2115-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-04-28 |
| Classified | 2017-05-18 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2018-07-03 |
| Distributed | CA, HI, IN, MN, NJ, PA, VA, WA, WI |
| Countries outside the US | AU, BR, CA, DE, IR, NG, NL |
| Quantity | 24 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024221475, 00889024221505 |
| Lot numbers | 63463357, 63463367 |
| Model numbers | 00-5988-020-14, 00-5988-020-17 |
| Expiration dates | 2026-09-30 |
Product
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Reason for recall
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2115-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.