FDA Device recall Z-1327-2023
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200 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-1327-2023 |
| 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 Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; 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 S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200, GTIN 00613994960955, Serial Numbers: A40821, A41333, A42693,…a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200, GTIN 00613994960955, Serial Numbers: A40821, A41333, A42693, A42811, A43336, A43592, A44884, A44960; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210, GTIN 00613994960948, Serial Numbers: A42415, A42482, A42953, A43212, A43354, A43965, A44760, A45028, A46673, A48105, A48484, A49062, A49564, A50856, A52420, A52719, A52904, A53373; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200, GTIN 00643169123052, Serial Numbers: A38910-046, A38910-047, A38910-048, A38910-049, A38910-050, A38910-051, A38910-052, A38910-053, A38910-054, A38910-055, A38910-056, A38910-057, A39374-061, A39374-062, A39374-063, A39374-064, A39374-065, A39374-066, A39374-067, A39374-068, A39374-069, A39374-070, A39374-071, A39374-072, A39736-021, A39736-022, A39736-023, A39736-024, A39736-025, A39736-026, A39736-027, A39736-028, A39736-029, A39736-030, A39736-031, A39736-032, A39803-051, A39803-052, A39803-053, A39803-054, A39803-055, A39803-056, A |
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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-1327-2023%22
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