—#123472

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.

FDA product code: FZX — Guide, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution: USA (nationwide) and Internationally to Japan.

Timeline

Recall initiated: 2013-10-25
Posted by FDA: 2013-11-22
Terminated: 2015-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123472. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.