Agency classClass IIOur severity:High FDA (Devices)·Z-2700-2018·Announced 2018-08-15

Howmedica Recalls 163 Orthopedic Radial Head Implants Due to Performance Concerns

Howmedica Osteonics Corp. is recalling 163 Radio Capitellum, Recon Head implants because literature reviews indicate a higher revision rate than other 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. The hazard involves a medical device that may not perform as expected, leading to a higher revision rate, which fits the criteria for a risk-of-harm product where injury has not yet been explicitly reported in the source text.

Plain-English summary

Howmedica Osteonics Corp. is recalling 163 units of the Radio Capitellum, Recon Head, Size #2. This orthopedic implant is used for the replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. The product was distributed nationwide in the United States.

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.

Patients who have received this implant should contact their healthcare provider for evaluation. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Radio Capitellum, Recon Head, Size #2. 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-malfunction
surgical-revision
Affected units: 163

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)

410-0007

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 →

Same manufacturer · Howmedica Osteonics Corp.

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