Recall Z-0098-2014— Small Bone Innovations, Inc.

Name: FDA recall Z-0098-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-06

Class II · Terminated

Class II FDA medical device recall by Small Bone Innovations, Inc., initiated 2013-09-06, terminated 2015-03-30. It names 6 FDA 510(k) clearances: K070236, K062898, K011819 and 3 more. 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.. Reason: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box..

Recalling firm: Small Bone Innovations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-06
Terminated: 2015-03-30
Firm location: Morrisville, PA, United States

510(k) clearances named in this recall

6 on FDA's record

K070236 — SBI LATERAL RADIO CAPITELLUMSmall Bone Innovations, Inc.·cleared 2007-02-21
K062898 — SBI LATERAL RHEAD IMPLANTSmall Bone Innovations, Inc.·cleared 2006-11-13
K011819 — RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc.·cleared 2001-06-19
K010786 — ULNAR HEAD IMPLANTAvanta Orthopaedics, Inc.·cleared 2001-04-11
K002644 — RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc.·cleared 2000-11-20
K982288 — RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc.·cleared 1998-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.