FDA-Device2024-09-18Class II
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
Zimmer GmbH
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
Sold states
Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Affected count
58 units
Manufactured in
Sulzerallee 8, Winterthur, Switzerland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3133-2024Don't want to check this manually?
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