FDA Device recall Z-1334-2023
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106 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-1334-2023 |
| 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 XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF T600612; 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 T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063,…a) DBM T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063, A41747-064, A41747-065, A41747-066, A41747-067, A41747-068, A41747-069, A41747-070, A41747-071, A41747-072, A41747-073, A43745-061, A43745-062, A43745-063, A43745-064, A43745-065, A43745-066, A43745-067, A43745-068, A43745-069, A43745-070, A43745-071, A43745-072, A43745-073, A43745-074, A43745-075, A43748-036, A43748-037, A43748-038, A43748-039, A43748-040, A46458-036, A46458-037, A46458-038, A46458-039, A46458-040, A46458-041, A46458-042, A46458-043, A46458-044, A46458-045, A46458-046, A46458-047, A46458-048, A49576-028, A49576-029, A49576-030, A49576-031, A49576-032, A49576-033, A49576-034, A49576-035, A49576-036, A49576-037, A49576-038, A49576-039, A49576-040; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206, GTIN 00643169218352, Serial Numbers: A38618-078, A38618-079, A38618-080, A38618-081, A38618-082, A38618-083, A38618-084, A38618-085, A38618-086, A38618-087, 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-1334-2023%22
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