FDA Device recall Z-1330-2023
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101 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-1330-2023 |
| 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: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; 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) PUTTY T50101 GRAFTON DBF 1CC, REF T50101, GTIN 00643169656017, Serial Numbers: A40005-036, A40005-037, A40005-038,…a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101, GTIN 00643169656017, Serial Numbers: A40005-036, A40005-037, A40005-038, A40005-039, A40005-040, A40005-041, A40005-042, A40005-043, A40005-045, A40005-046, A40005-047, A40005-048, A40005-049, A40005-051, A40005-053, A40005-054, A40005-055, A40005-056, A40005-057, A40005-058, A40005-059, A40005-060, A40005-061, A40005-062, A40005-063, A40005-064, A40005-065, A40005-066, A40005-067, A40005-068, A40005-069, A40005-070, A40005-071, A40005-072, A40005-073, A40005-074, A40005-075, A40005-076, A40005-077, A40005-078, A40005-079, A40005-080, A40005-081, A40005-082, A40005-083, A40005-084, A40005-085, A40005-086, A40005-087, A40005-088, A40005-089, A40005-090, A40005-091, A40005-092, A40005-093, A40005-094, A40005-095, A40005-096, A40005-097, A40005-098, A40005-099, A40005-100, A40005-101, A40005-102, A40304-210, A40304-211, A40304-212, A40304-213, A40304-214, A40304-215, A40304-216, A40304-217, A40304-218, A40304-219, A40304-220, A40304-221, A4030 |
|---|
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-1330-2023%22
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