Howmedica Recalls 387 Stryker rHead Bipolar Stem Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 387 units of the #4 Bipolar stem implant from the Stryker rHead system 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 387 units of the #4 Bipolar stem implant (Sterile packed), which is an orthopedic implant used for the replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. The recall is identified by the code RCN-S4.
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 post-surgery.
The affected units were distributed nationwide in the United States. Patients who have had this specific implant placed should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- #4 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
- 387
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-S4
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.
See all 70 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- HighStryker Triathlon size 3 baseplate packaging contained a size 4 implant
FDA (Devices) · 2026-06-24
- HighStryker Triathlon size 4 baseplate packaging contained a size 3 implant
FDA (Devices) · 2026-06-24
- HighStryker sagittal saw attachment cover screws may loosen and detach
FDA (Devices) · 2026-03-25
- ModerateCranial tracker devices recalled over an error message preventing use
FDA (Devices) · 2025-12-31
- ModerateHip stems recalled over potential mix of two catalog numbers in packaging
FDA (Devices) · 2025-10-08
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12