Locking Cortical Screw 3 — Class II medical device recall Z-0716-2014
Terminated recall by Biomet, Inc., reported 2014-01-22, distributed in AZ, CA, GA, IL, KY, MI, NC, NH…. 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx
| Recall number | Z-0716-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-12-19 |
| Classified | 2014-01-10 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2015-07-07 |
| Distributed | AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, VA |
| Quantity | 52 |
| Reason classes | labeling |
| Model numbers | 8161-35-038, 816135038 |
Product
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Reason for recall
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
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-0716-2014. 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.