FDA Device recall Z-1331-2023

Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303

FDA Device
Class II
ongoing
Published 2023-04-12

On 2023-04-12 the FDA classified a Class II recall of Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303 by Medtronic Sofamor Danek Usa, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1331-2023
Classification	Class II
Status	ongoing
Initiated	2023-02-08
Published	2023-04-12
Last updated	2026-09-13 11:56 UTC
Company	Medtronic Sofamor Danek Usa
Distribution	US

Product

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

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.

Identifiers

code_info	a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013,… a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, A460

code_info

a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013,…

a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, A460

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1331-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.