Howmedica Recalls Radio Capitellum Broach Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 10 units of the Radio Capitellum Broach Large, Right, due to a higher-than-expected revision rate and potential performance issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 indicates a risk of harm (device failure/revision) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 10 units of the Radio Capitellum Broach Large, Right, 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 product is identified by code 410-0303 and was distributed nationwide in the United States.
The recall was initiated because a literature review identified a revision rate for this device that is higher than other proximal radial head replacement devices. Consequently, the product may not perform at the expected level post-surgery.
Healthcare providers and patients who have used this specific implant should contact Howmedica Osteonics Corp. for further instructions regarding the recall and potential replacement or monitoring.
The recalled product
- Product
- Radio Capitellum Broach 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.
- Hazard
- Affected units
- 10
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)
- 410-0303
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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