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

Recall Z-2247-2017 — KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.

U.S. FDA — Device Enforcement · United States · 2017-05-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2247-2017
Date of alert
2017-05-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Sofamor Danek USA Inc
Product category
device
Product type
Devices
Reported risk: The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
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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