ClearanceBrief
Recall Z-0098-2014 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

Small Bone Innovations, Inc.

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 Co

DateOct 29, 2013 (initiated Sep 6, 2013)
StatusTerminated
ReasonThe recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Root causePackaging change control
ActionEmail 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.
Quantity2036 devices
DistributionWorldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K002644RADIAL HEAD IMPLANT
Avanta Orthopaedics, Inc., Nov 20, 2000
K010786ULNAR HEAD IMPLANT
Avanta Orthopaedics, Inc., Apr 11, 2001
K011819RADIAL HEAD IMPLANT
Avanta Orthopaedics, Inc., Jun 19, 2001
K062898SBI LATERAL RHEAD IMPLANT
Small Bone Innovations, Inc., Nov 13, 2006
K070236SBI LATERAL RADIO CAPITELLUM
Small Bone Innovations, Inc., Feb 21, 2007
K982288RADIAL HEAD IMPLANT
Avanta Orthopaedics, Inc., Sep 8, 1998