FDAFDA · Food and drugs·Recall number Z-3133-2024
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
Published September 18, 2024 · Recall initiated: August 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer GmbH
- Distributor
- Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
- Lot
- UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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