Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 124 Radio Capitellum, Recon Head, Size #4 orthopedic implants because the revision rate is higher 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, posing a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling 124 units of the Radio Capitellum, Recon Head, Size #4. This product is an orthopedic implant 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-2702-2018.
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, Recon Head, Size #4. 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.
- Hazard
- Affected units
- 124
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)
- 410-0009
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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