Various trauma and sports medicine instruments and implants — Class II medical device recall Z-1826-2016
Terminated recall by Biomet, Inc., reported 2016-06-01, distributed nationwide. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile bar
| Recall number | Z-1826-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-04-01 |
| Classified | 2016-05-26 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CO, CR, JP, KR, MX, MY, NL, PE |
| Reason classes | potency, sterility, packaging |
| Lot numbers | 625590 |
| Model numbers | 904756 |
Product
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Reason for recall
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
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-1826-2016. 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.