Recall Z-0906-2009 ยท EMG Forceps, Tooth Extractor, Surgical
Biomet Microfixation, Inc.
Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically. Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional.
| Date | May 21, 2008 |
| Status | Terminated |
| Reason | The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997. |
| Root cause | Labeling mix-ups |
| Action | Customers were contacted by e-mail notification with read receipt. Customers were notified in the e-mail to immediately discontinue use of the recalled product and return the affected items to Biomet Microfixation, Inc. The e-mail also included an Inventory Reconciliation form for customers to complete and return via fax (904-741-1801) to Biomet Microfixation, Inc. For questions related to this notice, please call 1-800-874-7711 or 904-741-4400 extension 448, Monday through Friday, 8 a.m.-4 p.m. Eastern Standard Time (EST). |
| Quantity | 4 |
| Distribution | International Distribution including countries of Ireland and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.