FDAFDA · Food and drugs·Recall number Z-0163-2024

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

Published November 1, 2023 · Recall initiated: September 26, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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 to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Medtronic Sofamor Danek USA Inc
Distributor: US, Colombia, S. Korea, New Zealand, India, Taiwan
Lot: a) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A58701-014, A58701-015, A58701-016, A58864-011, A58952-011, A58952-012, A58864-013, A58864-014, A58864-015, A58526-017, A59243-014, A58831-011, A58077-015, A58077-016, A58077-017, A58605-011, A58526-013, A59254-017, A57871-015, A57871-016, A58082-011, A59165-020, A59264-017, A59264-018, A56808-014, A58831-012, A59243-013, A59243-016, A59243-017, A59254-014, A59254-016, A59320-014, A58605-012, A58605-013, A58605-014, A58605-015, A57043-015, A58983-013, A58649-018, A58864-016, A58864-017, A59140-013, A59140-017, A59140-019, A59140-020, A59254-015, A59320-020, A59320-021, A57043-012, A58831-013, A58831-014, A56808-015, A57104-016, A58983-014, A58983-015, A58983-016, A59117-014, A59117-016, A59117-017, A57871-013, A58082-012, A58952-015, A59140-018, A59264-013, A58831-015, A58831-016, A58831-017, A58859-011, A57043-016, A58831-020, A58859-012, A58859-013, A58859-014, A59264-019, A59264-020, A59320-011, A59320-012, A59243-015, A59307-013, A59320-017, A59320-018, A58082-015, A58859-015, A59307-014, A59307-015, A58082-019, A58082-020, A58952-020, A59254-011, A57043-013, A58408-014, A59117-018, A59117-019, A58841-015, A58841-016, A58841-017, A58841-018, A59165-015, A59165-016, A59165-017, A59165-018, A57043-017, A57043-018, A58082-013, A58408-013, A59140-011, A59140-012, A57043-014, A58952-013, A58952-014, A58077-011, A58082-014, A59165-019, A57871-011, A57871-012, A58082-017, A58082-018, A59264-011, A59264-012, A58077-012, A59165-011, A58859-016, A58859-017, A57104-017, A58859-018, A56808-018, A57871-017, A58408-017, A59140-016, A58841-014, A58952-016, A59117-012, A59243-018, A59320-015, A59254-012; b) T42210: GTIN 00643169123069, Serial Numbers: A58133-043, A59122-023, A58133-046, A58518-019, A58518-020, A57362-017, A57362-019, A58545-022, A58133-045, A57362-011, A58545-028, A59122-022, A57344-020, A59122-017, A57344-021, A58133-044, A59122-018, A57344-022, A57344-018, A57344-019, A58545-024, A58518-015, A58545-011, A58545-012, A58133-047, A58518-011, A58518-012, A58518-013, A58518-014, A58122-011, A58122-012, A58122-013, A58122-014, A58122-015, A58122-016, A58122-017, A58122-018, A57344-023, A58518-016, A57387-026, A57387-027, A58518-017, A58518-018, A58545-013, A58545-014, A57387-029, A58518-031, A57344-024, A57387-011, A57387-012, A57387-013, A57387-014, A57387-015, A59122-019, A59122-020, A59122-021, A59122-024, A58518-021, A58518-022, A58518-023, A58518-024, A58518-025, A59200-013, A57362-012, A57362-013, A59200-014, A59200-015, A58545-016, A58545-023, A57387-024, A58545-015, A59122-025, A59122-026, A59122-027, A59200-011, A59200-012, A57344-013, A57344-025, A58545-017, A58545-018, A57344-017, A58133-041, A58133-042, A57387-016, A57387-017, A59200-016, A59200-017, A59200-018, A59200-019, A59200-020, A59200-021, A59200-022, A57387-028, A58133-036, A58133-040, A58545-029, A57362-014, A57362-015, A57362-016, A57387-018, A57387-019, A57387-020, A57387-021, A57387-022, A57387-023, A58122-019, A58122-020, A58122-021, A58122-022, A58122-023, A58133-039
Risk classification: Class II
Area (FDA): device
Country: United States

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