Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 6, 2013
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 po
The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Small Bone Innovations, Inc. recalled Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial S… - a moderate-severity action.
Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial S… was recalled by Small Bone Innovations, Inc. in November 6, 2013. Reason: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink…. Check the official notice for the remedy. Verify recall #Z-0098-2014 with the FDA Devices before acting.
The recall
Small Bone Innovations, Inc. issued this moderate-severity FDA Devices recall-The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- November 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0098-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0098-2014) was formally reported on November 6, 2013, with the manufacturer initiating the action on September 6, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Small Bone Innovations, Inc. is listed as the recalling firm, operating out of Morrisville, PA. Federal records list the affected scope as 2036 devices.
The documented reason for this recall is: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2036 devices
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0098-2014 |
| Date reported | November 6, 2013 |
| Date initiated | September 6, 2013 |
| Recalling firm | Small Bone Innovations, Inc. |
| Firm location | Morrisville, PA |
| Affected scope | 2036 devices |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0098-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Small Bone Innovations, Inc.. Units affected: 2036 devices.
Why was this product recalled? ▼
The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0098-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0098-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 6, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.