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

Recall Z-1324-2023 — Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DBM T44115INT 15CC GRA

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-1324-2023
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): 00613994961099

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

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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.

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