Recall Z-0381-2014— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2013-10-25, terminated 2015-05-06. FDA's recall record names no specific 510(k) clearance for this event. 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: Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-25
- Terminated
- 2015-05-06
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.