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U.S. Department of Health and Human Services

Class 2 Device Recall GENESYS Cross FT Suture Anchor with Two 2 (5 metric) HIFI Sutures

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 Class 2 Recall
GENESYS Cross FT Suture Anchor with Two 2 (5 metric) HIFI Sutures
see related information
Date Posted July 01, 2013
Recall Status1 Terminated on July 22, 2013
Recall Number Z-1619-2013
Recall Event ID 65166
Premarket Notification
510(K) Number
K101100 
Product Classification Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
Product GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
Code Information Product Number CFBC-4502, Lot #431437
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
Incorrect blue/white suture was used.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery on March 6, 2013, to notify all direct consignees of the recall. If the account no longer had the product in possess, they were asked to respond via a reply form or to contact ConMed Linvatec Customer Service to obtain a Service Request number for return and credit of unused unopened product. All returned product for this action would be identified, segregated and quarantined per the firm's procedures. Any returned product not part of the recall will be dispositioned in accordance with the firm's procedures. Please accept our sincere apology for any inconvenience this action may have caused . Should you have any questions please contact our Customer Service department at (800) 237-0169.
Quantity in Commerce 60 each of both units
Distribution US Distribution including the states of FL, KY, LA, MI, NC, and NY.
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.
510(K) Database 510(K)s with Product Code = MAI and Original Applicant = CONMED LINVATEC
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