RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002 Intended use: Preparation of the Radius prior to device implantation
This recall has been terminated (originally issued June 7, 2010).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- April 8, 2010
- Posted
- June 7, 2010
- Terminated
- May 17, 2011
- Recall Number
- Z-1779-2010
- Quantity
- 13 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Drill guides from 2 lots may not seat properly on the compression block.
Distribution
Worldwide: USA and The Netherlands
Lot / Code Info
Lot numbers: 0495581514, 089669448
Root Cause
Other
Action Taken
The firm, Wright Medical Technology, Inc., sent an "URGENT: Medical Device Voluntary Recall Letter" on April 8, 2010 via FedEx to customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please examine their inventory of the products and check it against the information provided, and to immediately return any affected products to Wright as soon as possible. The customers were also instructed to contact Customer service at 800-238-7117 for return instructions and replacement inventory. In addition, the customers were to immediately complete and return by fax at 901-867-7401 the attached response confirming receipt of the notice. If you have any questions regarding this matter, please contact Debby Daurer at 800-874-5630.