Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3132-2024·Announced 2024-09-18

Zimmer GmbH Recalls Mislabeled Biolox Option Taper Sleeve for Hip Replacement

Zimmer GmbH is recalling 69 units of Biolox Option Taper Sleeves due to incorrect packaging labels. The outer box may identify the wrong neck size, potentially leading to the use of the wrong device.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error that could lead to the use of the wrong device size, but no injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer GmbH is recalling 69 units of the Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck (Item Number: 650-1066). This medical device is indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. The recall is due to a labeling error where the outer packaging is labeled as a standard neck sleeve, but the product inside is a -6mm neck sleeve, and vice versa. The correct neck size can be identified by the device etching, which reads either STD or -6.

The affected units were distributed worldwide, including the United States, Japan, and the Netherlands. The specific lot number is 3185263, and the expiration date is November 30, 2033. The Unique Device Identifier (UDI) is (01)00887868271489(17)331130(10)3185263.

Healthcare providers and patients should check the etching on the device itself to verify the correct neck size before use. If a device is found with a mismatch between the packaging label and the device etching, it should not be used. Contact Zimmer GmbH for further instructions on how to return or replace the affected units.

The recalled product

Product: Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Manufacturer: Zimmer GmbH
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
wrong-device-use
Affected units: 69

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)00887868271489(17)331130(10)3185263 Lot Number: 3185263

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 →

Same manufacturer · Zimmer GmbH

See all →

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