Howmedica Recalls rHead Stem Implant 6mm Collar Size 4
Howmedica Osteonics Corp. is recalling 256 units of the rHead Stem Implant 6mm Collar, Size 4, because the revision rate is higher 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, and the source indicates a risk of harm (product may not perform as expected) without explicit reports of injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 256 units of the rHead Stem Implant 6mm Collar, Size 4. 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 affected units 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 product may not perform at the expected level after surgery.
Consumers and healthcare providers who have this specific implant should contact Howmedica Osteonics Corp. for further instructions on the recall.
The recalled product
- Product
- rHead Stem Implant 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.
- Hazard
- Affected units
- 256
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)
- 310-2017
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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