Class 2 Device Recall Small Bone Innovations (see also Product Description)

• Date Initiated by Firm: September 06, 2013
• Date Posted: October 29, 2013
• Recall Status: Terminated on March 30, 2015
• Recall Number: Z-0098-2014
• Recall Event ID: 66362
• 510(K)Number: K002644 K010786 K011819 K062898 K070236 K982288
• Product Classification: Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
• 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.
• Code Information: all item numbers and lot numbers.
• Recalling Firm/ Manufacturer: Small Bone Innovations, Inc.; 1711 S Pennsylvania Ave; Morrisville PA 19067-2507
• For Additional Information Contact: Customer Support; 215-428-1791
• Manufacturer Reason for Recall: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
• FDA Determined Cause: Packaging change control
• Action: Email correspondence and a notification letter, dated September 6, 2013, were sent to users requesting the immediate return of affected devices. Another notification letter, dated December 20, 2013 was also sent for recall of the additional devices after the recall was expanded.
• Quantity in Commerce: 2036 devices
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWI; 510(K)s with Product Code = KWI; 510(K)s with Product Code = KWI