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

Recall Z-1331-2023 — Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

U.S. FDA — Device Enforcement · United States · 2023-02-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1331-2023
Date of alert
2023-02-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Sofamor Danek USA Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000254001
Reported risk: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
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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