REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Biomet Trauma Persippany, NJ Rod,
FDA device recall Z-1478-2012 · posted 2012-04-30 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation
- Action taken
- Biomet sent an Urgent Medical Device Recall Notice dated April 18, 2012 to all affected consignees. The letter identified the affected product, reason for the recall including risks involved and actions to be taken. The notice provided directions to immediately locate and return the affected product. Receipt Confirmation was requested by calling 800-348-9500 Ext 3009 or 3983. FAX Back Response Form should be completed and returned to 574-372-1683. Questions should be direct to 574-371-3009 or 574-372-3983, M-F, 8 AM to 5 PM.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 30 units in total
- Distribution
- Worldwide Distribution - Nationwide (USA)
- Date initiated
- 2012-03-30
- Date posted
- 2012-04-30
- Date terminated
- 2013-03-08
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EBI TROCHANTERIC NAIL SYSTEM (K050118) | Ebi, L.P. | 2005-02-16 |