Device 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.
Z-0098-2014
Product summary
- Event
- Event 66362
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2036 devices
- Official record key
device-enforcement:Z-0098-2014
Official wording
Reason: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Code information: all item numbers and lot numbers.
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.
Derived failure modes
-
Unknown
The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.