Recall Z-2585-2010 ยท FZW Expander, Surgical, Skin Graft
Linvatec Corp. dba ConMed Linvatec
CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
| Date | Sep 28, 2010 (initiated Jan 29, 2010) |
| Status | Terminated |
| Reason | There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage. |
| Root cause | 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 | 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, T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.