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 bones for the fixation of fractures.
FDA Recall Z-1478-2012 · Posted 2012-04-30
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2012-03-30
Date Terminated2013-03-08
Product Quantity30 units in total
Reason for Recall
The Trochanteric Nail, lot 486130, was
mislabeled as a right nail orientation but the contents are actually a left nail orientation
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution - Nationwide (USA)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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