Howmedica Recalls Stryker Radial Head Implant Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 283 Stryker rHead Radial Head implants because literature suggests a higher revision rate 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 medical device that may not perform as expected, posing a risk of harm (revision surgery) without reported fatalities or specific injury counts, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Howmedica Osteonics Corp. is recalling 283 units of the Lateral Assembly, Radial Head Implant, 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 a revision rate for this specific device that is higher than 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 had this specific implant installed should contact their healthcare provider to discuss their individual circumstances and potential options for revision surgery.
The recalled product
- Product
- Lateral Assembly, Radial Head Implant, 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.
- Affected units
- 283
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)
- 310-0008
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.
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