Z-0098-2014Class II

Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral...

Name: Z-0098-2014 Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral...
Creator: Small Bone Innovations, Inc.
Published: 2013-09-06
License: https://open.fda.gov/license/

Small Bone Innovations, Inc. / initiated 2013-09-06 / Terminated / root cause: packaging

FDA source

Small Bone Innovations, Inc. began a recall of Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial... on 2013-09-06. FDA classified it as Class II and gives the reason as "The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0098-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-06
Posted: 2013-10-29
Terminated: 2015-03-30
Recalling firm: Small Bone Innovations, Inc.
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.
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Reason for recall: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Root cause tag: packaging
FDA root 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.
Product codes and lots: all item numbers and lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0098-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0098-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29

Product code KWI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)