FDA Device recall Z-1325-2023

Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090

FDA Device
Class II
ongoing
Published 2023-04-12

On 2023-04-12 the FDA classified a Class II recall of Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090 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-1325-2023
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 Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110; h) DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS; i) DBM T42110INT 2.5CMX5CM FLEXGRAFTON, REF T42110INT; j) DBM T42150INT 5CM X 5CM FLEX GRAFTON, REF T42150INT; 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) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b)… a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A

code_info

a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b)…

a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A

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-1325-2023%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.