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Zimmer GmbH Recall: Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for us

Zimmer GmbH Recall: Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for us is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Zimmer GmbH; Product: Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemente

Recalling firmZimmer GmbH
ProductBiolox 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
Reason for recallMislabeled: 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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Recall initiated20240808
Recall numberZ-3133-2024
Categorydevice
CountrySwitzerland

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