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
This recall has been terminated (originally issued September 22, 2010).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- August 26, 2010
- Posted
- September 22, 2010
- Terminated
- August 2, 2012
- Recall Number
- Z-2470-2010
- Quantity
- 13 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
Distribution
TX, PA, TN, VA, GA, and Spain
Lot / Code Info
Lot number 040754491
Root Cause
Process design
Action Taken
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.
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