The Recall Desk
HighFDA (Devices)·Z-2673-2018·Announced 2018-08-15

Howmedica Recalls Stryker Radial Head Implant Due to Revision Rate

Howmedica Osteonics Corp. is recalling 285 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.

What this means for you

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 (suboptimal performance) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.

Plain-English summary

Howmedica Osteonics Corp. is recalling 285 units of the Lateral Assembly, Radial Head Implant, Size 4. 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 affected units were 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 following surgery.

Consumers and healthcare providers should contact Howmedica Osteonics Corp. for further instructions regarding the recall. The agency has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Lateral Assembly, Radial Head Implant, Size 4. 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
Affected units
285

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)

  • 310-00010

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 →

Related recalls

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · suboptimal performance

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