Recall Z-1478-2012 ยท HSB Rod, Fixation, Intramedullary And Accessories
Biomet, Inc.
REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Biomet Trauma Persippany, NJ Rod, Fixation, Intramedullary and Accessories Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromiummolybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long
| Date | Apr 30, 2012 (initiated Mar 30, 2012) |
| Status | Terminated |
| Reason | The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 30 units in total |
| Distribution | Worldwide Distribution - Nationwide (USA) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050118 | EBI TROCHANTERIC NAIL SYSTEM Ebi, L.P., Feb 16, 2005 |