Recall Z-1211-03 ยท LXH Orthopedic Manual Surgical Instrument
Exactech, Inc.
Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.
| Date | Sep 11, 2003 (initiated Aug 1, 2003) |
| Status | Terminated |
| Reason | Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used. |
| Root cause | Other |
| Action | A recall letter dated July 31, 2003, requesting return of certain Tibial Augmentation Block Trials and an advisory (Field Advisory K-078) on the use of certain Tibial Tray Trials and Trapezoid Tibial Tray Trials. The recall letter gives the address to return product as: Exactech, 2243 NW 66th Court, Gainesville, FL. Consignees were told to immediately cease distribution or use of the recalled products and to return them. Also the letter asks them to extend the recall information to their user accounts and to read and comply with the instructions provided in the attached 'Field Advisory K-07 |
| Quantity | 169 |
| Distribution | Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.