Recall Z-1146-03 ยท LXH Orthopedic Manual Surgical Instrument
Exactech, Inc.
Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75.
| Date | Aug 26, 2003 (initiated Jul 30, 2003) |
| Status | Terminated |
| Reason | The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray. |
| Root cause | Other |
| Action | The firm mailed recall letters dated 7/30/2003 to direct distributor accounts requesting they cease distribution, subrecall to user accounts and return products to them at 2243 NW 66th Court, Gainesville, FL 32653. The firms were requested to respond to the recalling firm. |
| Quantity | 137 |
| Distribution | Product was distributed directly to four distributors in OH, ME, HI and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.