Z-0381-2014 Class II Terminated
FDA device recall Z-0381-2014 was initiated by Biomet, Inc. on Oct 25, 2013 and is designated Class II. Reason for recall: Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip. The recall status is terminated (terminated May 6, 2015). Affected quantity: 1130.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Oct 25, 2013
- Termination Date
- May 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1130
Product Description
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.
Distribution Pattern
Worldwide Distribution: USA (nationwide) and Internationally to Japan.
Code Information
Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0381-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026