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Terminated

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.

FDA Recall Z-0098-2014 · Posted 2013-10-29

Recalling FirmSmall Bone Innovations, Inc.
Recall StatusTerminated
Product CodeKWI
Date Initiated2013-09-06
Date Terminated2015-03-30
Product Quantity2036 devices

Reason for Recall

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

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070236SBI LATERAL RADIO CAPITELLUMSmall Bone Innovations, Inc. · 2007-02-21K062898SBI LATERAL RHEAD IMPLANTSmall Bone Innovations, Inc. · 2006-11-13K011819RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc. · 2001-06-19K010786ULNAR HEAD IMPLANTAvanta Orthopaedics, Inc. · 2001-04-11K002644RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc. · 2000-11-20K982288RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc. · 1998-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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