fastener — Class II medical device recall Z-1009-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-03-21, distributed in AL, CT, FL, IN, NC, NJ, NY, PA…. It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out
| Recall number | Z-1009-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-10-25 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-05-12 |
| Distributed | AL, CT, FL, IN, NC, NJ, NY, PA, TX, VA, WI |
| Quantity | 429 units |
| Reason classes | device malfunction |
| Lot numbers | 017350, 141990, 142000, 142020, 167190, 240720, 240740, 240770, 257970, 398710, 398730, 398740, 398750, 421780, 421790, 421800, 465910, 504120, 813190, 940370 |
| Model numbers | 110019010 |
Product
fastener, fixation, nondegradable, soft tissue
Reason for recall
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
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-1009-2018. 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.