The Recall Desk
HighFDA (Devices)·Z-2676-2018·Announced 2018-08-15

Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Performance Concerns

Howmedica Osteonics Corp. is recalling 81 units of Stryker rHead Radial Head Implant Assemblies because literature indicates higher revision rates than 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 (device underperformance requiring revision) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling 81 units of the Lateral Assembly, Radial Head Impl Assembly, 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 product was distributed nationwide in the United States.

The recall was initiated because a literature review identified that the revision rate for this 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 after surgery.

Patients who have had this specific implant installed should contact their healthcare provider to discuss the findings and determine if further evaluation or intervention is necessary.

The recalled product

Product
Lateral Assembly, Radial Head Impl Assembly, 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
81

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)

  • 310-00013

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 · device underperformance

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