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U.S. Department of Health and Human Services

Class 2 Device Recall CrossFT Suture Anchor with Two 2 HiFi Sutures

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  Class 2 Device Recall CrossFT Suture Anchor with Two 2 HiFi Sutures see related information
Date Initiated by Firm January 26, 2011
Date Posted June 29, 2011
Recall Status1 Terminated 3 on July 18, 2011
Recall Number Z-2703-2011
Recall Event ID 58936
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***"

The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
Code Information Lot 211581
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-392-6464
Manufacturer Reason
for Recall		 ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black).
FDA Determined
Cause 2		 Employee error
Action ConMed Linvatec sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product. Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at Custserv1@linvatec.com.
Quantity in Commerce 45 each
Distribution Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa.
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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