Howmedica Recalls Radial Head Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 128 Radial Head Assembly Size #2 implants because literature reviews indicate higher revision rates 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. The hazard involves a medical device that may not perform as expected, leading to higher revision rates, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 128 units of the Radial Head Assembly Size #2, part of the Stryker rHead Radial Head and Uni-Elbow system. These orthopedic implants are designed for the replacement of the proximal end of the radius. The recall is 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.
The source text does not specify specific actions for consumers or patients, nor does it report any specific injuries or illnesses associated with the use of these implants.
The recalled product
- Product
- Radial Head Assy Size #2, Rad. 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
- 128
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)
- 410-0004
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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