ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: ...

FDA Recall #Z-0871-2020 — Class II — December 19, 2019

Recall #Z-0871-2020 Date: December 19, 2019 Classification: Class II Status: Terminated

Product Description

ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

Reason for Recall

Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

Recalling Firm

Zimmer Biomet, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

67 units

Distribution

US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS

Code Information

Lot Numbers: 827310, 711160, 203240

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated