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

Recall Z-1593-2013 — INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

U.S. FDA — Device Enforcement · United States · 2013-05-28 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1593-2013
Date of alert
2013-05-28
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: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
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.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.