| Class 2 Device Recall Grafix Tendon Stripper |  |
Date Initiated by Firm | January 29, 2010 |
Date Posted | September 28, 2010 |
Recall Status1 |
Terminated 3 on January 12, 2011 |
Recall Number | Z-2585-2010 |
Recall Event ID |
54561 |
Product Classification |
Expander, Surgical, Skin Graft - Product Code FZW
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Product | CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA. |
Code Information |
Lot Numbers 11708A, 11708B, 11708C, 11708D, 11708E |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
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For Additional Information Contact | Roger Murphy 727-392-6464 |
Manufacturer Reason for Recall | There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage. |
FDA Determined Cause 2 | Process control |
Action | Recall Notification Letters were sent to customers on January 29, 2010. Customers were requested to complete and return a Customer Response Form indicating the number of products available for return and number distributed. Each distributor was asked to notifiy their customers if the product was further distributed. |
Quantity in Commerce | 149 |
Distribution | Distributed throughout U.S. and Internationally to Arab Emirates, Belgium, Canada, China, Columbia, Cyprus, Germany, Denmark, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Republic of Korea, Lithuania, Morocco,
Malaysia, Poland, Portugal, Saudi Arabia, El Salvador, Thailand, Taiwan and Viet Nam.
Domestic Distribution to CA, FL, GA, IL, IN, KS, MI, MT, NY, OH, PA, TX, and WA. |
Total Product Life Cycle | TPLC Device Report |
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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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