Z-0098-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2013
- Initiation Date
- September 6, 2013
- Termination Date
- March 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2036 devices
Product Description
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.
Reason for Recall
The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.
Code Information
all item numbers and lot numbers.