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U.S. Department of Health and Human Services

Class 2 Device Recall Grafix Tendon Stripper

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 Class 2 Device Recall Grafix Tendon Strippersee related information
Date Initiated by FirmJanuary 29, 2010
Date PostedSeptember 28, 2010
Recall Status1 Terminated 3 on January 12, 2011
Recall NumberZ-2585-2010
Recall Event ID 54561
Product Classification Expander, Surgical, Skin Graft - Product Code FZW
ProductCONCEPT 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
For Additional Information ContactRoger 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
ActionRecall 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 Commerce149
DistributionDistributed 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 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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