Recall Z-1704-2009 ยท LXH Orthopedic Manual Surgical Instrument
Smith & Nephew Inc
IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
| Date | Aug 4, 2009 (initiated Jan 22, 2009) |
| Status | Terminated |
| Reason | Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long. |
| Root cause | Process design |
| Action | Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product. |
| Quantity | 99 units |
| Distribution | Distribution to USA, Switzerland and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.