REF 200068 Security — Class II medical device recall Z-0381-2014
Terminated recall by Biomet, Inc., reported 2013-12-04, distributed nationwide. Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance throu
| Recall number | Z-0381-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-10-25 |
| Classified | 2013-11-22 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 1,130 |
| Model numbers | 200068 |
Product
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
Reason for recall
Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
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-0381-2014. 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.