FDA Recall
Terminated
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
Recall: Z-2470-2010
·
Initiated August 26, 2010
Recall
- Recall Number
- Z-2470-2010
- Event Number
- 56667
- Firm
- Wright Medical Technology Inc
- FEI Number
- 1043534
- Product Code
- HXX
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- August 26, 2010
- Posted
- September 22, 2010
- Terminated
- August 2, 2012
- Address
- 5677 Airline Rd, Arlington, TN, 38002-9501
Description
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
Reason
After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
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.
Distribution
TX, PA, TN, VA, GA, and Spain
Quantity
13 units