FDAClass IIJuly 22, 2015

ZNN Antegrade Femoral Nail recall

ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.

Why was ZNN Antegrade Femoral Nail recalled?

A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.

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 47-2492-320-10; lot 62763724

Product
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Recalling firm
Zimmer, Inc.
Quantity
8
Distribution
Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls