Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthope
FDA device recall Z-1521-2012 · posted 2012-05-10 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Incorrect product picture label was on the product box.
- Action taken
- Biomet Orthopedics sent an Urgent Medical Device Recall Notice dated April 18,2012, to all affected customers. The letter identified the reason for the recall including directions to immediately locate, discontinue use of the device, and return product to Biomet, 56 East Bell Drive, Warsaw, IN 46580. Consignees were asked to confirm receipt of the notice by calling 1-800-348-9500 extension 3983 or 3009. A FAX Back Response Form was to be filled out and sent within 3 days of receipt to 574-372-1683. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m. For questions regarding this recall call 574-371-1021.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JXE
- Quantity affected
- 30 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Europe, Austrailia
- Date initiated
- 2012-04-18
- Date posted
- 2012-05-10
- Date terminated
- 2013-04-18
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRA-DRIVE 3 (K031280) | Biomet, Inc. | 2003-09-22 |