FDA Device recall Z-0716-2014
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 by Biomet, citing 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 Locki….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0716-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-19 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, VA |
Product
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Reason
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.
Identifiers
| code_info | Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0716-2014%22
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