FDAClass IIDecember 4, 2013

Synthes Titanium Cannulated Humeral Nail Intended to recall

Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Why was Synthes Titanium Cannulated Humeral Nail Intended to recalled?

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

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 # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517

Product
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Recalling firm
Synthes USA HQ, Inc.
Quantity
14
Distribution
Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
Recall date
December 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls