Howmedica Recalls Stryker Radial Head Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 1,213 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 involves a risk-of-harm product (orthopedic implant) where the hazard is a higher revision rate and potential performance failure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 1,213 units of the Stryker rHead Radial Head and Uni-Elbow system, specifically the radial head implant #3 (Sterile packed). The product is an orthopedic implant designed for the replacement of the proximal end of the radius. The recall is classified as Class II by the U.S. Food and Drug Administration.
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 post-surgery.
The affected units were distributed nationwide in the United States. The specific product code is RHA-H3. Patients who have received this implant should consult their healthcare provider to discuss the findings and determine if further medical evaluation or intervention is necessary.
The recalled product
- Product
- radial head implant #3 (Sterile packed). 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
- 1,213
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)
- RHA-H3
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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