Recalls / —
—#94207
Product
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
- FDA product code
- HXX — Screwdriver
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot number 040754491
Why it was recalled
After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
Root cause (FDA determination)
Process design
Action the firm took
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.
Recalling firm
- Firm
- Wright Medical Technology Inc
- Address
- 5677 Airline Rd, Arlington, Tennessee 38002-9501
Distribution
- Distribution pattern
- TX, PA, TN, VA, GA, and Spain
Timeline
- Recall initiated
- 2010-08-26
- Posted by FDA
- 2010-09-22
- Terminated
- 2012-08-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #94207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.