Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S450

Summary

The FDA issued a Class II for Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b by Medtronic Sofamor Danek USA Inc. Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a .

Details

Product Description

Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product

Lot/Code Info: a) DBM S45001 GRAFTON 1CC PASTE, REF S45001, GTIN 00613994961037, Serial Numbers: A46006, A40308, A42539, A43901, A44220, A45597, A45671, A46339, A48873, A51546, A52593, A52757, A53414; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005, GTIN 00613994961020, Serial Numbers: A40309, A43891, A45123, A45614, A46395, A46625, A46708, A48098, A48545, A48646, A48920, A49642, A50256, A51481, A51591, A52422, A52947, A53416, A53534, A53685, A53927, A54681; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010, GTIN 00613994961013, Serial Numbers: A48673, A40169, A41945, A42622, A42931, A43105, A43124, A43340, A43904, A44606, A45676, A46344, A46456, A46730, A47917, A48147, A48149, A48275, A48980, A49864, A50243, A51016, A51041, A51755, A52183, A52329, A52709, A52713, A52954, A53755, A53944, A54258, A54365, A54784, A54804, A54988; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001, GTIN 00643169122949, Serial Numbers: A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, A24679-161, A24679-162, 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A43346-107, A43346-108, A43346-109, A43346-110, A43346-111, A43346-112, A43346-113, A43346-114, A43346-115, A43346-116, A43571-041, A43571-042, A43571-043, A43571-044, A43571-045, A43571-046, A43571-047, A43571-048, A43571-049, A43571-050, A43571-051, A43571-052, A43571-053, A43571-054, A43571-055, A43571-056, A43571-057, A43571-058, A43571-059, A43571-060, A43571-061, A43571-062, A43571-063, A43571-064, A43571-065, A43571-066, A43571-067, A43571-068, A43571-069, A43571-070, A43571-071, A43571-072, A43571-073, A43571-074, A43571-075, A43571-076, A43571-077, A43571-078, A43571-079, A43571-080, A43571-081, A43571-082, A43571-083, A43571-084, A43571-085, A43571-086, A43571-087, A43571-088, A43571-090, A43571-091, A43571-092, A43571-093, A43571-094, A43632-071, A43632-072, A43632-073, A43632-074, A43632-075, A43632-076, A43632-077, A43632-078, A43632-079, A43632-080, A43632-081, A43632-082, A43632-083, A43632-084, A43632-085, A43632-086, A43632-087, A43632-088, A43632-089, A43632-090, A43632-091, A43632-092, A43632-093, A43632-094, A43632-095, A43632-096, A43632-097, A43632-098, A43632-099, A43632-100, A43632-102, A43632-103, A43632-104, A43632-105, A43632-106, A43632-107, A43632-108, A43632-109, A43632-110, A43632-111, A43632-112, A43632-113, A43632-114, A43632-115, A43632-116, A43632-117, A43632-118, A43632-119, A43632-120, A43632-121, A43632-122, A43632-123, A43632-124, A43632-125, A43632-126, A43632-127, A43632-128, A43632-129, A43632-130, A43632-131, A43632-132, A43632-133, A43632-134, A43632-135, A43632-136, A43632-137, A43632-138, A43632-139, A43632-140, A43632-141, A43632-143, A43632-144, A43632-145, A43744-037, A43744-038, A43744-039, A43744-040, A43744-041, A43744-042, A43744-043, A43744-044, A43744-045, A43744-046, A43744-047, A43744-048, A43744-049, A43744-050, A43744-051, A43744-052, A43744-053, A43744-054, A43744-055, A43744-056, A43744-057, A43744-058, A43744-059, A43744-060, A43744-061, A43744-062, A43744-063, A43744-064, A43744-065, A43744-066, A43744-067, A43744-068, A43744-069, A43744-070, A43744-071, A43744-072, A43744-073, A43744-074, A43744-075, A43744-076, A43744-077, A43744-078, A43744-079, A43744-080, A43744-081, A43744-082, A43744-083, A43744-084, A43744-085, A43744-086, A43744-087, A43744-088, A43744-089, A43744-090, A43744-091, A43744-092, A43744-093, A43744-094, A43744-095, A43744-096, A43744-097, A43744-098, A43744-099, A43744-100, A43744-101, A43744-102, A43744-103, A43744-104, A43744-105, A43744-106, A43744-107, A43744-108, A43744-109, A43744-110, A43744-111, A43744-112, A43744-113, A43744-114, A43744-115, A43744-116, A44173-031, A44173-032, A44173-033, A44173-034, A44173-035, A44173-036, A44173-037, A44173-038, A44173-039, A44173-040, A44173-041, A44173-042, A44173-043, A44173-044, A44173-045, A44173-046, A44173-047, A44173-048, A44173-049, A44173-050, A44173-051, A44173-052, A44173-053, A44173-054, A44173-055, A44173-056, A44173-057, A44173-058, A44173-059, A44173-060, A44173-061, A44173-062, A44173-063, A44173-064, A44173-065, A44173-066, A44173-067, A44173-068, A44173-069, A44173-070, A44173-071, A44173-072, A44173-073, A44173-074, A44173-075, A44173-076, A44173-077, A44173-078, A44173-079, A44173-080, A44173-081, A44173-082, A44173-083, A44173-084, A44173-085, A44317-011, A44317-012, A44317-013, A44317-014, A44317-015, A44317-016, A44317-017, A44317-018, A44317-019, A44317-020, A44317-021, A44317-022, A44317-023, A44317-024, A44317-025, A44317-026, A44317-027, A44317-028, A44317-029, A44317-030, A44317-031, A44317-032, A44317-033, A44317-034, A44317-035, A44317-036, A44317-037, A44317-038, A44317-039, A44317-040, A44317-041, A44317-042, A44317-043, A44317-044, A44317-045, A44317-046, A44317-047, A44317-048, A44317-0

Quantity Affected: 37721 units

Reason for Recall

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-08

Company