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Zimmer GmbH Recall 95231

Description: 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 Recall 95231 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-3133-2024
Event ID95231
Event DescriptionBiolox 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
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Quantity58 units
Recall ReasonMislabeled: 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
Device Classification20240918
Device Code InfoUDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266
Center Classification Date20240912
Recall Initiation Date20240808
Recalling FirmZimmer GmbH
Initial Notification Letter
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