PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 26, 2018 Initiated: October 31, 2018 #Z-0630-2019

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

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
19 units
Distribution
Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 19 units.
Why was this product recalled?
Screw is missing from the package
Which agency issued this recall?
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0630-2019.