Recall Z-0105-04 ยท HTZ Instrument, Cutting, Orthopedic
Exactech, Inc.
Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
| Date | Nov 11, 2003 (initiated Jun 17, 2003) |
| Status | Terminated |
| Reason | Instrument is excessively flexible making it unusable by the surgeon. |
| Root cause | Other |
| Action | The firm mailed a Recall Notification Letter to each account on June 17, 2003 asking them to cease distribution, return recalled product to them and to subrecall to any accounts they may have distributed to. |
| Quantity | 18 |
| Distribution | Product was distributed to five distributors in the following states: LA, ME, NV, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.