Agency classClass IIOur severity:High FDA (Devices)·Z-2694-2018·Announced 2018-08-15

Howmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Revision Rates

Howmedica Osteonics Corp. is recalling 214 Radio Capitellum Small, Left orthopedic implants because literature reviews indicate higher revision rates than similar devices.

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 is classified as FDA Class II, and the hazard involves a risk of harm (device underperformance requiring revision) without reported injuries or illnesses in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling 214 units of the Radio Capitellum Small, Left orthopedic implant. This product is part of the Stryker rHead Radial Head and Uni-Elbow system and is used for the replacement of the proximal end of the radius. The recall number is Z-2694-2018, and the product code is 410-0001.

The recall was initiated because a literature review identified that the revision rate for this specific device is higher than that of other proximal radial head replacement devices. The source text notes that the product may not perform at the expected level post-surgery.

The affected units were distributed nationwide in the United States. The source text does not specify the exact dates of distribution or the specific facilities where the implants were used. Consumers and healthcare providers should contact Howmedica Osteonics Corp. for further instructions regarding the recall and potential replacement or removal of the device.

The recalled product

Product: Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Orthopedic Implant
Hazard: device-underperformance
surgical-revision
Affected units: 214

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)

410-0001

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 70 recalled by 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 70 products in this recall →

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