Recall Z-1900-2010 ยท LXH Orthopedic Manual Surgical Instrument
Smith & Nephew Inc
GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA Drill guide used as manual surgical instrument during knee replacement surgeries.
| Date | Jun 24, 2010 (initiated Apr 20, 2010) |
| Status | Terminated |
| Reason | Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side |
| Root cause | Process control |
| Action | All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to sho |
| Quantity | 12 units |
| Distribution | International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.