Medtronic Sofamor Danek USA Inc: Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

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.

Details from the source

Reason for recall: 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. Distribution: US, Colombia, S. Korea, New Zealand, India, Taiwan Quantity: 377 units Lot/code info: 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,

UPC codes

00643169123052, 00643169123069

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.