Howmedica Recalls 605 Bipolar Radial Head Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 605 sterile bipolar radial head implants 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, and the hazard involves a medical device that may not perform as expected, posing a risk of harm without reported fatalities or specific injury counts.
Plain-English summary
Howmedica Osteonics Corp. is recalling 605 units of the #2 Bipolar radial head Implant (Sterile packed). These orthopedic implants are designed for the replacement of the proximal end of the radius and are part of 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 post-surgery.
Patients who have received this implant should contact their healthcare provider for further evaluation and guidance regarding their specific clinical situation.
The recalled product
- Product
- #2 Bipolar radial head Implant (Sterile packed). 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
- 605
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)
- RCN-H2
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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