Recall Z-1871-2008 ยท EMM Chisel, Osteotome, Surgical
Biomet Microfixation, Inc.
Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting).
| Date | Sep 11, 2008 (initiated Apr 16, 2008) |
| Status | Terminated |
| Reason | The working tips of the Stella Osteotomes are thicker than specification. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified its consignees on 4/16/08 by certified mail with return receipt. Sub-accounts were contacted by email. All returned product will be stored in quarantine until a final determination of disposition is made. |
| Quantity | 36 |
| Distribution | Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.