Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The Biomet Offset
FDA device recall Z-1061-2009 · posted 2009-04-07 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JDW
- Quantity affected
- 17
- Distribution
- Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.
- Date initiated
- 2009-02-13
- Date posted
- 2009-04-07
- Date terminated
- 2009-08-11
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OFFSET TIBIAL TRAY (K010212) | Biomet, Inc. | 2001-02-14 |