Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). The source indicates a higher revision rate and potential failure to perform as expected, which aligns with significant structural/functional concerns.
Plain-English summary
Howmedica Osteonics Corp. is recalling 133 units of the rHead Recon Stem Implant non-coated, Size 2. 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 products were 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. Consequently, the product may not perform at the expected level after surgery.
Patients who have received this implant should contact their healthcare provider for further evaluation and guidance regarding their specific situation.
The recalled product
- Product
- rHead Recon Stem Implant non-coated, Size 2. 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
- 133
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)
- RCN-S260
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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