Z-0992-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-0992-2018 was initiated by Zimmer Biomet, Inc. on June 30, 2017 and is designated Class II. Reason for recall: Product may contain the presence of melted sterile packaging upon opening. The recall status is terminated (terminated April 13, 2018). Affected quantity: 30.

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
June 30, 2017
Termination Date
April 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30

Product Description

DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

Reason for Recall

Product may contain the presence of melted sterile packaging upon opening.

Distribution Pattern

US in the state of Texas

Code Information

part number: 650-1162 lot number: 2016030466