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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 Device Recall All in one CrossFT Punchsee related information
Date Initiated by FirmApril 09, 2012
Date PostedOctober 29, 2012
Recall Status1 Terminated 3 on November 21, 2013
Recall NumberZ-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 FL 33773-4908
For Additional Information ContactRoger 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		Process control
ActionLinvatec 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 Commerce2 units
DistributionWorldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
Total Product Life CycleTPLC 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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