Howmedica Recalls Radial Head Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 690 Lateral Assembly, Radial Head Implant, Size 3 units because literature indicates 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 hazard involves a risk-of-harm product (orthopedic implant) where performance issues may lead to injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 690 units of the Lateral Assembly, Radial Head Implant, Size 3. This orthopedic implant is used for the replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. The product was 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.
Patients who have received this implant should contact their healthcare provider to discuss the findings and determine the appropriate course of action.
The recalled product
- Product
- Lateral Assembly, Radial Head Implant, Size 3. 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
- 690
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)
- 310-0009
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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