Grafton DBM Orthoblend recall
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Why was Grafton DBM Orthoblend recalled?
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) T44125INT: GTIN 00643169965058, Serial Numbers: A52559-042, A52559-024, A52559-038, A52559-039, A52559-040, A52559-041, A52559-044, A52559-045, A52559-021, A52559-022, A52559-023, A52559-025, A52559-026, A52559-027, A52559-028, A52559-029, A52559-030, A52559-031, A52559-032, A52559-033, A52559-034, A52559-035, A52559-036, A52559-037, A52559-043; b) T44135: GTIN 00643169122918, Serial Numbers: A59102-034, A59102-035, A58789-025, A58789-026, A58789-027, A59080-036, A59080-037, A58789-030, A58789-031, A58789-032, A58789-033, A58789-034, A58789-035, A58789-036, A58789-037, A58789-038, A58789-039, A59102-042, A59102-043, A59102-044, A59102-045, A59102-046, A59102-047, A59102-048, A59102-049, A59102-050, A59102-051, A59103-030, A59103-031, A59103-032, A59103-033, A59103-034, A59103-035, A59103-036, A59103-037, A59103-038, A59103-039, A59102-055, A59102-056, A58789-061, A58789-062, A59080-022, A59080-026, A59080-027, A59080-028, A59080-029, A59080-030, A59102-038, A59102-039, A59102-040, A59102-041, A59102-059, A59102-060, A59102-061, A59102-062, A58789-047, A59103-042, A59103-043, A59103-044, A59103-045, A59103-046, A58789-028, A58789-029, A59080-020, A59080-021, A59080-023, A59102-031, A59102-032, A59102-033, A59080-024, A59080-025, A59102-029, A59103-040, A59080-031, A59080-016, A59080-017, A58789-042, A58789-043, A58789-044, A58789-045, A58789-046, A58789-048, A58789-049, A58789-021, A58789-022, A58789-023, A59080-019, A59102-057, A59102-058, A59103-041, A58789-050, A58789-054, A58789-055, A58789-056, A58789-057, A58789-058, A58789-059, A58789-060, A59103-016, A59103-017, A59103-018, A59103-029, A59080-018, A59102-028, A59102-030, A59102-052, A59102-053, A59102-054; c) T44145: GTIN 00643169122925, Serial Numbers: A56911-076, A56911-070, A56911-071, A56911-023, A56911-067, A47028-065, A56911-082, A59197-041, A59197-059, A56911-074, A56911-075, A47028-053, A57248-034, A56911-018, A59197-057, A59197-036, A59197-037, A59197-020, A59197-021, A59197-022, A59197-023, A59197-024, A56911-028, A56911-029, A56911-030, A56911-031, A56911-033, A57248-039, A56911-034, A56911-035, A56911-080, A59197-034, A56911-077, A56911-078, A56911-079, A59197-047, A59197-044, A56911-068, A56911-044, A56911-045, A56911-046, A56911-081, A57248-020, A57248-032, A57248-036, A59197-062, A56911-032, A59197-055, A59197-051, A59197-052, A57248-025, A57248-026, A57248-027, A57248-028, A57248-029, A56911-041, A59197-048, A56911-020, A56911-024, A56911-025, A56911-047, A56911-048, A56911-049, A56911-050, A56911-051, A56911-052, A56911-053, A56911-054, A56911-055, A56911-056, A56911-057, A56911-058, A56911-042, A56911-043, A56911-072, A56911-073, A57248-013, A57248-014, A47028-036, A47028-037, A47028-038, A56911-059, A47028-039, A56911-027, A47028-040, A59197-011, A59197-012, A59197-013, A47028-059, A57248-033, A59197-018, A59197-019, A47028-066, A47028-067, A59197-049, A59197-050, A47028-041, A47028-042, A59197-040, A47028-043, A47028-044, A57248-011, A57248-012, A59197-025, A59197-026, A59197-027, A59197-028, A59197-029, A59197-030, A59197-031, A59197-032, A59197-033, A56911-019, A56911-021, A56911-022, A56911-060, A56911-061, A56911-062, A56911-063, A56911-064, A56911-065, A56911-066, A57248-030, A57248-031, A57248-035, A59197-038, A59197-039, A59197-060, A59197-061, A57248-038, A59197-054, A47028-045, A47028-046, A47028-047, A47028-048, A59197-014, A59197-015, A59197-016, A59197-017, A56911-069, A59197-045, A57248-015, A57248-016, A57248-017, A57248-018, A56911-036, A56911-037, A56911-038, A56911-039, A56911-040, A47028-049, A47028-050, A47028-051, A47028-052, A57248-037, A59197-064, A59197-065, A47028-054, A59197-042, A59197-043, A59197-053, A56911-026, A59197-056, A57248-019, A47028-055, A47028-056, A59197-046, A59197-063, A59197-058, A47028-057, A47028-058, A59197-035; d) T44150: GTIN 00643169122932, Serial Numbers: A48245-164, A48245-168, A57914-011, A57914-012, A57914-023, A57914-024, A57914-025, A59191-061, A59191-058, A58758-035, A58758-036, A58758-037, A58758-059, A59191-038, A59191-039, A58758-034, A58758-038, A59191-040, A48245-121, A48245-122, A48245-123, A48245-124, A48245-147, A48245-148, A48245-149, A48245-160, A48245-170, A58758-060, A58758-061, A58758-062, A59191-062, A59191-063, A59191-064, A58758-039, A57914-013, A57914-014, A57914-015, A57914-016, A57914-017, A58758-040, A58758-041, A58758-042, A59191-041, A58758-043, A58758-044, A48245-165, A48245-166, A48245-167, A48245-169, A58758-045, A58758-046, A58758-050, A58758-051, A58758-047, A58758-048, A58758-049, A59191-042, A59191-043, A59191-044, A58758-031, A58758-032, A58758-033, A59191-045, A59191-046, A59191-047, A59191-048, A59191-049, A48245-135, A48245-136, A48245-137, A48245-138, A48245-139, A48245-140, A48245-141, A48245-142, A48245-143, A48245-144, A48245-145, A48245-146, A48245-150, A48245-151, A48245-152, A48245-153, A48245-154, A48245-155, A48245-156, A48245-157, A57914-018, A57914-019, A57914-020, A57914-021, A57914-022, A48245-161, A48245-125, A48245-126, A48245-127, A48245-128, A48245-129, A48245-130, A48245-131, A48245-132, A48245-133, A48245-134, A48245-158, A48245-159, A48245-162, A59191-050, A59191-051, A48245-163, A58758-052, A59191-052, A59191-053, A58758-063, A59191-060, A58758-053, A58758-054, A58758-055, A59191-054, A59191-055, A59191-059, A58758-056, A58758-057, A58758-058, A59191-056, A59191-057
- Product
- Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 430 units
- Distribution
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Recall date
- November 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)