Home / Recalls / Zimmer GmbH / Z-3132-2024

Z-3132-2024 Class II Ongoing

Recalled by Zimmer GmbH — Winterthur

Recall Details

Product Type
Devices
Report Date
September 18, 2024
Initiation Date
August 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69 units

Product Description

Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066

Reason for Recall

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.

Code Information

UDI: (01)00887868271489(17)331130(10)3185263 Lot Number: 3185263

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