Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 170 Radio Capitellum Large, Left orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
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 text indicates a risk of harm (product may not perform at expected level) without reporting specific 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 170 units of the Radio Capitellum Large, Left orthopedic implant. This product is part of the Stryker rHead Radial Head and Uni-Elbow system and is used for the replacement of the proximal end of the radius. The recall number is Z-2693-2018.
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 specific dates of distribution or identify specific patients affected. Consumers and healthcare providers should contact Howmedica Osteonics Corp. for further instructions regarding the recall.
The recalled product
- Product
- Radio Capitellum Large, Left 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
- 170
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)
- 410-0000
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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