Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 141 rHead Recon Stem Implants because literature reviews indicate higher revision rates than other 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 the hazard involves a risk of harm (device failure/revision) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Howmedica Osteonics Corp. is recalling 141 units of the rHead Recon Stem Implant, non-coated, Size 3. 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 number is Z-2719-2018.
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.
The affected units were distributed nationwide in the United States. The recall code is RCN-S360. Patients who have received this implant should contact their healthcare provider to discuss the findings and determine the appropriate next steps for their care.
The recalled product
- Product
- rHead Recon Stem Implant non-coated, Size 3. 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
- 141
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-S360
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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