Recall Z-2470-2010 ยท HXX Screwdriver
Wright Medical Technology Inc
DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
| Date | Sep 22, 2010 (initiated Aug 26, 2010) |
| Status | Terminated |
| Reason | After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake. |
| Root cause | Process design |
| Action | The firm initiated their recall the product by letter on 08/26/2010. The letters were addressed to distributors and hospital administrators with a fax back response form. Please contact Customer Service at 800-238-7117, if you have any questions. |
| Quantity | 13 units |
| Distribution | TX, PA, TN, VA, GA, and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.