REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use O

FDA device recall Z-0381-2014 · posted 2013-11-22 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

FZX

Quantity affected

1130

Distribution

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

Date initiated

2013-10-25

Date posted

2013-11-22

Date terminated

2015-05-06

Location

Warsaw, IN