FDAFDA · Food and drugs·Recall number Z-0381-2014
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.
Published December 4, 2013 · Recall initiated: October 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide Distribution: USA (nationwide) and Internationally to Japan.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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