Small Bone Innovations, Inc. recalls Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Rad

Recalled November 6, 2013 · FDA recall Z-0098-2014 · Small Bone Innovations

Hazard

The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. · FDA Class II

Units

2036 devices

Sold at

Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.

Description

The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

Product

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.

Manufacturer(s)

Small Bone Innovations, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →