CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
This recall has been terminated (originally issued September 28, 2010).
- Recall Initiated
- January 29, 2010
- Posted
- September 28, 2010
- Terminated
- January 12, 2011
- Recall Number
- Z-2585-2010
- Quantity
- 149
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.
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.
Lot / Code Info
Lot Numbers 11708A, 11708B, 11708C, 11708D, 11708E
Root 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.