Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns
Howmedica Osteonics Corp. is recalling 90 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
What this means for you
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 a higher revision rate, which fits the criteria for a risk-of-harm product where injury has not yet been explicitly reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 90 units of the rHead Recon Stem Implant non-coated, Size 1. 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 recall was initiated because a literature review identified that the revision rate for this product 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 recall code is RCN-S160.
Patients who have had this implant placed should contact their healthcare provider to discuss the recall and potential options for management.
The recalled product
- Product
- rHead Recon Stem Implant non-coated, Size 1. 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
- 90
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-S160
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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