Recall Z-0381-2014
Biomet, Inc. · initiated October 25, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0381-2014
- Initiated
- October 25, 2013
- Posted by FDA
- November 22, 2013
- Terminated
- May 6, 2015
- Product code
- FZX – Guide, Surgical, Instrument
- Quantity
- 1130
- Distribution
- Worldwide Distribution: USA (nationwide) and Internationally to Japan.
- Recalling firm
- Biomet, Inc., Warsaw, IN