Howmedica Recalls rHead Radial Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 162 units of rHead Radial 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 are assigned a score of 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling 162 units of the rHead, Radial Implant 6 mm Collar, 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 specific product code is RHA-S360.
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 source text does not specify which patients or facilities received these units, nor does it report any specific injuries or illnesses associated with the device.
The recalled product
- Product
- rHead, Radial Implant 6 mm Collar, 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
- 162
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-S360
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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