Stryker Radial Stem Implant Recalled Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 492 Stryker rHead Radial Stem Implants because literature reviews indicate higher revision rates 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. Per the rubric, risk-of-harm products where injury has not yet been reported (the source notes performance concerns but no specific injuries) align with a High severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling 492 units of the Lateral Assembly, Radial Stem Implant, Size 3. 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 post-surgery.
No specific dates, lot numbers, or reported injuries are provided in the source text. Consumers and healthcare providers should refer to the official FDA recall notice for specific instructions on how to handle the recalled units.
The recalled product
- Product
- Lateral Assembly, Radial Stem Implant, Size 3. 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
- 492
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)
- 310-0002
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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