Recall Z-3133-2024— Zimmer GmbH
Class II · Ongoing
Class II FDA medical device recall by Zimmer GmbH, initiated 2024-08-08. It names one FDA 510(k) clearance: K082996. Product: 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. Reason: 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.
- Recalling firm
- Zimmer GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-08
- Firm location
- Winterthur, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.