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ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal… recallZ-2060-2015 · Zimmer, Inc. · initiated Jun 17, 2015

Class II Terminated All recalls posted in July 2015

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 Zimmer, 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

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.

FDA root cause category: Process control

What the company is doing

On 6/17/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.

Recall details

Recall number
Z-2060-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 17, 2015
Posted by the FDA
Jul 13, 2015
Recalling firm
Zimmer, Inc.
Quantity
8
Product code
HSB
FDA submissions
K083497
Distribution
Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.

Product description

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

Code information (models, lots, serial numbers)

Part 47-2492-320-10; lot 62763724

Other devices under the same FDA submission

12 devices cleared under K083497 — 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

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