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.
FDA Recall Z-0381-2014 · Posted 2013-11-22
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeFZX
Date Initiated2013-10-25
Date Terminated2015-05-06
Product Quantity1130
Reason for Recall
Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
Firm Action
10/25/2013 Urgent Medical Device Recall Notifications were sent to each Distributor and Risk/Recall Manager at each direct account identifying the recalled device, possible adverse health consequences and instructing consignees to immediately locate and remove devices from circulation, following instructions on the FAX back form and returning it within 3 business days to FAX 574-372-1683 and returning product to Biomet Return Goods, 56 East Bell Drive Warsaw In 46580. Questions should be directed to 574-372-1570 M-F, 8 a.m. to 5 p.m.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: USA (nationwide) and Internationally to Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.