Reported Apr 12, 2023 · Ongoing
Medtronic Grafton DBF
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 Grafton DBF
6 of 6 products
| Model / number | Product as published |
|---|---|
T50101 | PUTTY T50101 GRAFTON DBF 1CC |
T50101INT | PUTTY T50101INT GRAFTON DBF 1CC |
T50103 | PUTTY T50103 GRAFTON DBF 3CC |
T50103INT | PUTTY T50103INT GRAFTON DBF 3CC |
T50106 | PUTTY T50106 GRAFTON DBF 6CC |
T50106INT | PUTTY T50106INT GRAFTON DBF 6CC, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) PUTTY T50101 GRAFTON DBF 1CCREF T50101GTIN 00643169656017
- Serial Numbers
2,710 of 2,710 codes
A40005-036A40005-037A40005-038A40005-039A40005-040A40005-041A40005-042A40005-043A40005-045A40005-046A40005-047A40005-048A40005-049A40005-051A40005-053A40005-054A40005-055A40005-056A40005-057A40005-058A40005-059A40005-060A40005-061A40005-062A40005-063A40005-064A40005-065A40005-066A40005-067A40005-068A40005-069A40005-070A40005-071A40005-072A40005-073A40005-074A40005-075A40005-076A40005-077A40005-078A40005-079A40005-080A40005-081A40005-082A40005-083A40005-084A40005-085A40005-086A40005-087A40005-088A40005-089A40005-090A40005-091A40005-092A40005-093A40005-094A40005-095A40005-096A40005-097A40005-098
- Amount recalled
- 47436 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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