Recall Z-1061-2009 ยท JDW Pin, Fixation, Threaded
Biomet, Inc.
Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valg
| Date | Apr 7, 2009 (initiated Feb 13, 2009) |
| Status | Terminated |
| Reason | A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert. |
| Root cause | Packaging process control |
| Action | Consignees were notified by "Field Safety Corrective Action" letter dated February 13, 2009 to conduct a recall to the hospital level and to locate and return the recalled product to Biomet Orthopedics. Customers were also instructed to complete the enclosed "Fax Back Response Form" and return it via fax to Biomet Orthopedics at 1-574-372-1683. Direct questions about this recall to 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8 a.m. to 5 p.m. |
| Quantity | 17 |
| Distribution | Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010212 | OFFSET TIBIAL TRAY Biomet, Inc., Feb 14, 2001 |