Reported Apr 12, 2023 · Ongoing
Medtronic XPANSE Bone Insert
Medtronic Sofamor Danek USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Pl · Memphis, TN · 38132-1703
Is this the product you have?
Medtronic XPANSE Bone Insert
6 of 6 products
| Model / number | Product as published |
|---|---|
T600106 | DBM T600106 XPANSE SMALL-C 6 |
T600206 | DBM T600206 XPANSE MEDIUM-C 6 |
T600209 | DBM T600209 XPANSE MEDIUM-C 9 |
T600306 | DBM T600306 XPANSE LARGE-C 6 |
T600309 | DBM T600309 XPANSE LARGE-C 9 |
T600612 | DBM T600612 XPANSE LARGE-L, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM T600106 XPANSE SMALL-C 6REF T600106GTIN 00643169218314
- Serial Numbers
62 of 62 codes
A41747-061A41747-062A41747-063A41747-064A41747-065A41747-066A41747-067A41747-068A41747-069A41747-070A41747-071A41747-072A41747-073A43745-061A43745-062A43745-063A43745-064A43745-065A43745-066A43745-067A43745-068A43745-069A43745-070A43745-071A43745-072A43745-073A43745-074A43745-075A43748-036A43748-037A43748-038A43748-039A43748-040A46458-036A46458-037A46458-038A46458-039A46458-040A46458-041A46458-042A46458-043A46458-044A46458-045A46458-046A46458-047A46458-048A49576-028A49576-029A49576-030A49576-031A49576-032A49576-033A49576-034A49576-035A49576-036A49576-037A49576-038A49576-039A49576-040b) DBM T600206 XPANSE MEDIUM-C 6
- Serial Numbers
1,499 of 1,499 codes
A38618-078A38618-079A38618-080A38618-081A38618-082A38618-083A38618-084A38618-085A38618-086A38618-087A38618-088A38618-089A38618-090A38618-091A38618-092A38618-093A38618-094A38618-095A38618-096A38618-097A38618-098A38618-099A38618-100A38618-101A38618-102A38618-103A38618-104A38618-105A38618-106A38618-107A38618-108A38618-109A38618-110A38618-111A38618-112A38618-113A38618-114A38618-115A38618-116A38618-117A38618-118A38618-119A38618-120A38618-121A38618-122A38618-123A38618-124A38618-125A38618-126A38618-127A38618-128A38618-129A38618-130A38618-131A39566-044A39566-045A39566-046A39566-047A39566-048A39566-049
- Serial Numbers
665 of 665 codes
A40169-098A40169-099A40169-100A40169-101A40169-102A40169-103A40169-104A40169-105A40169-106A40169-107A40169-108A40169-109A40169-110A40169-111A40169-112A40169-113A40169-114A40169-115A40169-116A40169-117A40169-118A40169-119A40169-120A40169-121A40169-122A40169-123A40169-124A40169-125A40169-126A40169-127A40169-128A40169-129A40169-130A40169-131A40169-132A40169-133A40169-134A40169-135A40169-136A40169-137A40169-138A40169-139A40169-140A40169-141A40169-142A40734-040A40734-041A40734-042A40734-043A40734-044A40734-045A40734-046A40734-047A40734-048A40734-049A40734-050A40734-051A40734-052A40734-053A40734-054
- Serial Numbers
471 of 471 codes
A38618-018A38618-019A38618-020A38618-021A38618-022A38618-023A38618-024A38618-025A38618-026A38618-027A38618-028A38618-029A38618-030A38618-031A38618-032A38618-033A38618-034A38618-035A38618-036A38618-037A38618-038A38618-039A38618-040A38618-041A38618-042A38618-043A38618-044A38618-045A38618-046A38618-047A38618-048A38618-049A38618-050A38618-051A38618-052A38618-053A38618-054A38618-055A38618-056A38618-057A38618-058A38618-059A38618-060A38618-061A38618-062A38618-063A38618-064A38618-065A38618-066A38618-067A38618-068A38618-069A38618-070A38618-071A38618-072A38618-073A38618-074A38618-075A38618-076A38618-077
- Amount recalled
- 4348 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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