Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Coll...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0098-2014.
The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0098-2014.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Small Bone Innovations, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0098-2014.
Small Bone Innovations, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Small Bone Innovations, Inc. Recall FAQ
Small Bone Innovations, Inc. is the subject of a medical implants safety report: Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Coll.... The notice was published on September 6, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 2,036 units are potentially affected.