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REF 28234 Troch Nail, Long 11MM, Right 34 CM recallZ-1478-2012 · Biomet, Inc. · initiated Mar 30, 2012

Terminated All recalls posted in April 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-1478-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 30, 2012
Posted by the FDA
Apr 30, 2012
Recalling firm
Biomet, Inc.
Quantity
30 units in total
Product code
HSB
FDA submissions
K050118
Distribution
Worldwide Distribution - Nationwide (USA)

Product description

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.

Code information (models, lots, serial numbers)

Item 28334, Lot M486130

Other devices under the same FDA submission

13 devices cleared under K050118 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page