Howmedica Recalls Stryker rHead Radial Head Bipolar Stem Implants
Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants used in the Stryker rHead system due to a higher-than-expected revision rate.
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 or failure, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants (Sterile packed) used in 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 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 indicates that the product may not perform at the expected level post-surgery. The recall is classified as Class II by the U.S. Food and Drug Administration. The affected units were distributed nationwide in the United States.
Patients who have had this specific implant placed should contact their healthcare provider to discuss the recall and determine if any follow-up action is necessary. The recall code for this action is RCN-S3.
The recalled product
- Product
- #3 Bipolar stem implant (Sterile packed). 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
- 673
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-S3
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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