Recall Z-0630-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0630-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-31

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-10-31, terminated 2019-04-08. It names one FDA 510(k) clearance: K152494. Product: NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.. Reason: Screw is missing from the package.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-31
Terminated: 2019-04-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K152494 — Zimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsZimmer, Inc.·cleared 2015-11-25

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¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.

Reason for recall

Screw is missing from the package

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