Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0098-2014 — 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 R

U.S. FDA — Device Enforcement · United States · 2013-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0098-2014
Date of alert
2013-09-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Small Bone Innovations, Inc.
Product category
device
Product type
Devices
Reported risk: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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