Stryker Radial Stem Implant Recalled Due to Higher Revision Rates
Howmedica Osteonics is recalling 280 Stryker rHead Radial Stem Implants because literature reviews show higher revision rates than 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 involves a medical device with a higher-than-expected revision rate, indicating a risk of harm where injury has not yet been explicitly reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 280 units of the Lateral Assembly, Radial Stem Implant, Size 4. 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.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it provide specific dates or lot numbers beyond the code 310-0003.
The recalled product
- Product
- Lateral Assembly, Radial Stem Implant, 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
- 280
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)
- 310-0003
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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