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

Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON — recall Z-1323-2023

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-1323-2023
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): 00613994960900

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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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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