Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or performance issues that may require corrective action (revision) are rated as Severe.
Plain-English summary
Howmedica Osteonics Corp. is recalling 33 units of the rHead Standard Extended Stem, 6mm Collar, Size 1. 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. The source text notes that the product may not perform at the expected level following surgery.
This recall is classified as Class II by the FDA. Patients who have received this implant should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- rHead Standard Extended Stem, 6mm Collar, Size 1. 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
- 33
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)
- 410-0100
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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