Howmedica Recalls Stryker Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 607 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 product (orthopedic implant) where performance issues are identified but specific injury reports are not detailed in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 607 units of the radial head implant #2 (Sterile packed), code RHA-H2, used in the Stryker rHead Radial Head and Uni-Elbow system. These orthopedic implants are designed for the replacement of the proximal end of the radius. The products 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 post-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
- radial head implant #2 (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
- 607
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-H2
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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