Small Bone Innovations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0098-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 6, 2013

Date Posted: November 6, 2013

Recall Number: Z-0098-2014

Event ID: 66362

Reason for Recall:

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

Status: Terminated

Product Quantity: 2036 devices

Code Information:

all item numbers and lot numbers.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated