Recall Z-1779-2010 ยท LXH Orthopedic Manual Surgical Instrument
Wright Medical Technology Inc
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
| Date | Jun 7, 2010 (initiated Apr 8, 2010) |
| Status | Terminated |
| Reason | Drill guides from 2 lots may not seat properly on the compression block. |
| Root cause | Other |
| Action | 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 im |
| Quantity | 13 units |
| Distribution | Worldwide: USA and The Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.