Recall Z-2585-2010
Linvatec Corp. dba ConMed Linvatec · initiated January 29, 2010
Product
CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
Codes / lots: Lot Numbers 11708A, 11708B, 11708C, 11708D, 11708E
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: Process control
Action taken
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.
Details
- Recall number
- Z-2585-2010
- Initiated
- January 29, 2010
- Posted by FDA
- September 28, 2010
- Terminated
- January 12, 2011
- Product code
- FZW – Expander, Surgical, Skin Graft
- Quantity
- 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…
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec, Largo, FL