CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
FDA device recall Z-2585-2010 · posted 2010-09-28 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Reason for recall
- There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FZW
- Quantity affected
- 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, Jap
- Date initiated
- 2010-01-29
- Date posted
- 2010-09-28
- Date terminated
- 2011-01-12
- Location
- Largo, FL
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