Howmedica rHead Recon Stem Implant Recalled for Performance Concerns
Howmedica Osteonics Corp. is recalling 216 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.
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 source indicates a risk of harm (product may not perform at expected level) without explicit reports of injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 216 units of the rHead Recon Stem Implant 6mm Collar, Size 4. 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 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. Consequently, the product may not perform at the expected level following surgery.
Healthcare providers and patients who have received this implant should contact Howmedica Osteonics Corp. for further instructions regarding the recall and potential replacement or monitoring.
The recalled product
- Product
- rHead Recon Stem Implant 6mm Collar, Size 4. 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
- 216
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)
- 310-2025
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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