Zimmer, Inc. recalls NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty w…

Recall date

April 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1575-2015

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.