Zimmer, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1575-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 2, 2015

Date Posted: May 13, 2015

Recall Number: Z-1575-2015

Event ID: 71009

Reason for Recall:

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

Status: Terminated

Product Quantity: 20 units

Code Information:

Part #00-5990-036-10; lot 62815809

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated