Biolox Taper Sleeve Mislabeling: Wrong Component Size in Hip Replacement
Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeling where packaging labels one neck size but contains the opposite size. These components are used in hip replacement surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving mislabeling of a surgical implant component. No illnesses or injuries have been reported. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' which scores 3 (High).
Plain-English summary
Zimmer GmbH is recalling the Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck (Item Number 650-1064), a component used in total hip replacement surgery.
The recall is due to mislabeling of the outer packaging. The packaging is labeled as either a standard neck or -6mm neck taper sleeve, but the actual product inside the box is the opposite configuration. For example, a package labeled as a standard neck sleeve may contain a -6mm sleeve, and vice versa. The correct component size can be identified by examining the etching on the device itself, which indicates either 'STD' or '-6'.
This device is indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components.
The recall affects 58 units that were distributed worldwide, including the United States, Japan, and the Netherlands.
The recalled product
- 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
- Manufacturer
- Zimmer GmbH
- Affected units
- 58
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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