Affixus Hip Fracture Nail Left 130 11 mm x 360 mm — Class II medical device recall Z-0165-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-10-24, distributed nationwide. There were complaints indicating that when the product was opened in surgery, the sterile packaging was alread
| Recall number | Z-0165-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-08-08 |
| Classified | 2018-10-17 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2020-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, NL |
| Quantity | 14 |
| Reason classes | sterility |
| Lot numbers | 289190 |
| Model numbers | 814611360 |
Product
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Reason for recall
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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-0165-2019. 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.