Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants
Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). The higher revision rate implies significant performance issues.
Plain-English summary
Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant (Sterile packed). 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 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.
Patients who have had this specific implant installed should contact their healthcare provider to discuss the recall and potential options for revision surgery. The recall is classified as Class II by the FDA.
The recalled product
- Product
- #2 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
- 543
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-S2
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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