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NexGen Augment recallZ-1575-2015 · Zimmer, Inc. · initiated Apr 2, 2015

Class II Terminated All recalls posted in May 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

The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery

FDA root cause category: Mixed-up of materials/components

What the company is doing

On 4/2/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. All distributors were notified via electronic mail, 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 between 8:00 am and 5:00pm EST.

Recall details

Recall number
Z-1575-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 2, 2015
Posted by the FDA
May 1, 2015
Recalling firm
Zimmer, Inc.
Quantity
20 units
Product code
JWH
FDA submissions
K960279
Distribution
Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.

Product description

NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.

Code information (models, lots, serial numbers)

Part #00-5990-036-10;  lot 62815809

Other devices under the same FDA submission

63 devices cleared under K960279 — 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