Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 268 units of the rHead Stem Implant 6mm Collar, Size 2, 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 injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 268 units of the rHead Stem Implant 6mm Collar, 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 affected units were distributed nationwide in the United States.
The recall was initiated because a literature review identified that the revision rate for this specific product 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 after surgery.
The source text does not specify specific actions for consumers or patients. Individuals who have had this implant should consult their healthcare provider for guidance regarding the recall and potential next steps.
The recalled product
- Product
- rHead Stem Implant 6mm Collar, 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
- 268
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)
- 310-2015
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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