FDAClass IIDecember 18, 2013

Synthes Trochanteric Fixation Nail As recall: Labeling Error

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and…

Why was Synthes Trochanteric Fixation Nail As recalled?

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Product
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and…
Recalling firm
Synthes USA HQ, Inc.
Quantity
12
Distribution
Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
Recall date
December 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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