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U.S. Department of Health and Human Services

Class 2 Device Recall Security Enclosed Carpal Tunnel Security Blade

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  Class 2 Device Recall Security Enclosed Carpal Tunnel Security Blade see related information
Date Initiated by Firm October 25, 2013
Date Posted November 22, 2013
Recall Status1 Terminated 3 on May 06, 2015
Recall Number Z-0381-2014
Recall Event ID 66792
Product Classification Guide, surgical, instrument - Product Code FZX
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.
Code Information 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
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1676
Manufacturer 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 2		 Nonconforming Material/Component
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.
Quantity in Commerce 1130
Distribution Worldwide Distribution: USA (nationwide) and Internationally to Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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