FDA Device recall Z-1332-2023

Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203

FDA Device
Class II
ongoing
Published 2023-04-12

On 2023-04-12 the FDA classified a Class II recall of Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203 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-1332-2023
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 Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; 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) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012,… a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A4548

code_info

a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012,…

a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A4548

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-1332-2023%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.