Reported Apr 12, 2023 · Ongoing
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005;…
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?
11 of 11 products
| Model / number | Product as published |
|---|---|
S45001 | DBM S45001 GRAFTON 1CC PASTE |
S45005 | DBM S45005 GRAFTON 5CC PASTE |
S45010 | DBM S45010 GRAFTON 10CC PASTE |
T45001 | DBM T45001 1CC PASTE GRAFTON PLUS |
T45001AUS | DBM T45001AUS 1CC PASTE GRAFTON PLUS |
T45001INT | DBM T45001INT 1CC PASTE GRAFTON PLUS |
T45005 | DBM T45005 5CC PASTE GRAFTON PLUS |
T45005INT | DBM T45005INT 5CC PASTE GRAFTON PLUS |
T45010 | DBM T45010 10CC PASTE GRAFTON PLUS |
T45010AUS | DBM T45010AUS 10CC PASTE GRAFTON PLUS |
T45010INT | DBM T45010INT 10CC PASTE GRAFTON PLUS, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM S45001 GRAFTON 1CC PASTEREF S45001GTIN 00613994961037
- Serial Numbers
A46006A40308A42539A43901A44220A45597A45671A46339A48873A51546A52593A52757A53414b) DBM S45005 GRAFTON 5CC PASTEREF S45005GTIN 00613994961020
- Serial Numbers
A40309A43891A45123A45614A46395A46625A46708A48098A48545A48646A48920A49642A50256A51481A51591A52422A52947A53416A53534A53685A53927A54681c) DBM S45010 GRAFTON 10CC PASTEREF S45010GTIN 00613994961013
- Serial Numbers
A48673A40169A41945A42622A42931A43105A43124A43340A43904A44606A45676A46344A46456A46730A47917A48147A48149A48275A48980A49864A50243A51016A51041A51755A52183A52329A52709A52713A52954A53755A53944A54258A54365A54784A54804A54988d) DBM T45001 1CC PASTE GRAFTON PLUSREF T45001GTIN 00643169122949
- Serial Numbers
2,641 of 2,641 codes
A24679-156A24679-157A24679-158A24679-159A24679-160A24679-161A24679-162A24679-163A24679-164A24679-165A24679-166A24679-167A24679-168A24679-169A24679-170A24679-171A24679-172A24679-173A24679-176A24679-177A24679-178A24679-179A24679-180A24679-181A24679-182A24679-183A24679-184A24679-185A24679-186A24679-187A24679-188A24679-189A24679-190A24679-191A24679-192A24679-193A24679-194A24679-195A24679-196A24679-197A24679-198A24679-199A24679-200A24679-201A24679-202A24679-203A24679-204A24679-205A24679-206A24679-207A24679-208A24679-209A24679-210A24679-211A24679-212A24679-213A24679-214A24679-215A24679-216A24679-217
- Amount recalled
- 37721 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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