Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Small Bone Innovations (SBi) rHead Radial Stem Recalled by Small Bone Innovations, Inc. Due to The recall was initiated due to an increased...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Small Bone Innovations, Inc. directly.
Affected Products
Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.
Quantity: 2036 devices
Why Was This Recalled?
The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report