Recall Z-1575-2015— Zimmer, Inc.

Name: FDA recall Z-1575-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-02

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2015-04-02, terminated 2015-09-23. It names one FDA 510(k) clearance: K960279. Product: 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.. Reason: 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.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-02
Terminated: 2015-09-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K960279 — NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACESZimmer, Inc.·cleared 1996-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.