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U.S. Department of Health and Human Services

Class 2 Device Recall All in one CrossFT Punch

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 Class 2 Recall
All in one CrossFT Punch
see related information
Date Posted October 29, 2012
Recall Status1 Terminated on November 21, 2013
Recall Number Z-0164-2013
Recall Event ID 63090
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
Code Information Lot # 330889 and Catalog: PFT-00M - No Expiration date
Recalling Firm/
Manufacturer
Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo, Florida 33773-4908
For Additional Information Contact Roger Murphy
727-392-6464
Manufacturer Reason
for Recall
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Linvatec Corp sent a Urgent Medical Device Recall Notification letter dated April 9, 2012, to all affected customers. The letter was sent via FEDEx and by e-mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory for the recalled product and segregate them for return to the recalling firm. Furthermore, return the products along with the "REPLY FORM". Should you have any further questions please contact our Customer Service department at (800) 237-0169.
Quantity in Commerce 2 units
Distribution Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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