Howmedica Recalls rHead Standard Extended Stem Orthopedic Implants
Howmedica Osteonics Corp. is recalling 36 units of rHead Standard Extended Stem implants due to a higher-than-expected revision rate and potential performance issues.
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 (device failure/revision) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Howmedica Osteonics Corp. is recalling 36 units of the rHead Standard Extended Stem, 6mm Collar, Size 4. These are orthopedic implants used for the replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. The affected 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. The source text notes that the product may not perform at the expected level after surgery.
Consumers and healthcare providers should contact Howmedica Osteonics Corp. for further instructions regarding the recall and potential replacement or removal of the affected implants.
The recalled product
- Product
- rHead Standard Extended Stem, 6mm Collar, 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.
- Affected units
- 36
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)
- 410-0103
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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