Stryker rHead Radial Head Implant Recall Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 150 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. The hazard involves a medical device that may not perform as expected, leading to a higher revision rate, which fits the criteria for a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 150 units of the Lateral Assembly, Radial Head Impl Assembly, 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 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.
The source text does not specify specific actions for consumers or patients, nor does it report any specific injuries or illnesses. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Lateral Assembly, Radial Head Impl Assembly, 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
- 150
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)
- 310-00011
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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