DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC
FDA device recall Z-2470-2010 · posted 2010-09-22 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 13 units
- Distribution
- TX, PA, TN, VA, GA, and Spain
- Date initiated
- 2010-08-26
- Date posted
- 2010-09-22
- Date terminated
- 2012-08-02
- Location
- Arlington, TN
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