Zimmer GmbH: Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064

Hazard

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

Details from the source

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: Worldwide distribution - US Nationwide and the countries of Japan, Netherlands. Quantity: 58 units Lot/code info: UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266

UPC codes

00887868271465

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.