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

Recall Z-0866-2021 — OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

U.S. FDA — Device Enforcement · United States · 2019-06-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0866-2021
Date of alert
2019-06-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Skeletal Kinetics, Llc
Product category
device
Product type
Devices
Reported risk: A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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