Recall Z-1329-2023— Medtronic Sofamor Danek USA Inc

Name: FDA recall Z-1329-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-08

Class II · Ongoing

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2023-02-08. It names one FDA 510(k) clearance: K043048. Product: Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product. Reason: 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..

Recalling firm: Medtronic Sofamor Danek USA Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-02-08
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K043048 — GRAFTON PLUS DBM PASTEOsteotech, Inc.·cleared 2005-11-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.