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.
Reported: December 4, 2013 Initiated: October 25, 2013 #Z-0381-2014
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 1130
- Distribution
- Worldwide Distribution: USA (nationwide) and Internationally to Japan.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 1130.
Why was this product recalled? ▼
Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2013. Severity: Moderate. Recall number: Z-0381-2014.
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