Howmedica Recalls 158 Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 158 Radio Capitellum Large, Right orthopedic 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 source text explicitly states that the product may not perform at the expected level post-surgery, indicating a risk of harm where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 158 units of the Radio Capitellum Large, Right orthopedic implant. This product is used for the replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. The recall number is Z-2695-2018.
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.
The affected units were distributed nationwide in the United States. The source text does not specify the number of patients affected or report any specific injuries or illnesses. Consumers and healthcare providers should contact Howmedica Osteonics Corp. for further instructions regarding the recall.
The recalled product
- Product
- Radio Capitellum Large, Right. 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
- 158
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)
- 410-0002
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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