Agency classClass IIOur severity:High FDA (Devices)·Z-2089-2012·Announced 2012-08-01

Stryker Recalls ABG II Modular Hip Stems for Corrosion Risk

Stryker is recalling ABG II Modular Hip Stems to update instructions due to a reported rate of less than one percent for revisions associated with fretting and corrosion.

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: The recall involves a medical device with a reported rate of revisions due to fretting and corrosion, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling the ABG II Modular Hip Stem. The recall involves 9,003 units that were distributed nationwide. The product consists of 8 right stems and 8 left stems, with necks made of GADS Vitallium, a proprietary Co Cr alloy.

The recall is a product correction to update the instruction for use (IFU). This action is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction. On June 29, 2012, Stryker decided to remove the affected product from the field.

The source text does not specify specific actions for consumers or patients beyond the removal of the product from the field. The recall is classified as Class II by the FDA.

The recalled product

Product: ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS…
Manufacturer: Stryker Howmedica Osteonics Corp.
Category: Medical Device — Orthopedic Implant
Hazard: corrosion
fretting
Affected units: 9,003

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)

510 K092406 all lots (4845-4XXX and NLS/NLV)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Stryker Howmedica Osteonics Corp. 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 · Stryker Howmedica Osteonics Corp.

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Same hazard · corrosion