Medtronic Sofamor Danek USA Inc recalls Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T422

Hazard / Issue

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.

Issued by

FDA

Distribution: US, Colombia, S. Korea, New Zealand, India, Taiwan

Lot/Code Info: a) T42275: GTIN 00643169123076, Serial Numbers: A58988-042, A58156-043, A59160-040, A59343-027, A58156-049, A58988-029, A58821-051, A58156-050, A59343-029, A59343-030, A59343-031, A59343-032, A59343-033, A59269-016, A59154-026, A59343-043, A59160-046, A59154-038, A59154-039, A59154-040, A59154-041, A59154-042, A58821-048, A58821-049, A59343-020, A59343-021, A59343-024, A59343-025, A59343-026, A58821-056, A58821-057, A58988-040, A59154-031, A59160-044, A58988-018, A58821-026, A58821-027, A58821-028, A58821-029, A58821-030, A58988-019, A58988-020, A58988-021, A59119-027, A58156-042, A58821-053, A58821-054, A58821-055, A58988-043, A58988-044, A58988-045, A59119-011, A59119-012, A59119-013, A59119-014, A59119-015, A59119-016, A59119-017, A59119-032, A59119-033, A59119-034, A59154-014, A59154-015, A59154-016, A59160-018, A59160-019, A59343-011, A59343-012, A59343-013, A59160-035, A59160-036, A59160-037, A58821-021, A58821-022, A58988-022, A58988-023, A58821-031, A58821-032, A58988-024, A59343-014, A59343-015, A58821-024, A58821-025, A59119-030, A59119-031, A58988-025, A58988-026, A58988-027, A58988-028, A59160-016, A59160-029, A59160-030, A59160-031, A59160-032, A59343-016, A59343-017, A59343-018, A58821-033, A59119-018, A59154-043, A59154-044, A59160-033, A59160-042, A59160-043, A58988-030, A58821-050, A59119-019, A59119-020, A59119-021, A59119-022, A59119-023, A59119-024, A59119-025, A59154-025, A59160-041, A59160-048, A59160-049, A58821-052, A58988-041, A59154-018, A59154-024, A59160-020, A59343-028, A58988-011, A58988-012, A59160-012, A59160-013, A59160-015, A58156-032, A58156-035, A58821-034, A58821-035, A58821-036, A59154-017, A59160-024, A59160-034, A59269-018, A58821-037, A58821-038, A58988-031, A58988-032, A58988-033, A58988-034, A58821-039, A58821-040, A59154-030, A58156-051, A59119-028, A59119-029, A59160-047, A59269-017, A58821-041, A58821-023, A58988-013, A58988-014, A58988-015, A59119-026, A59154-034, A59154-045, A59154-046, A59160-011, A59343-019, A58988-035, A59160-017, A58821-042, A58988-037, A59343-034, A58156-052, A59154-033, A59269-012, A59269-013, A59269-014, A59269-015, A58156-045, A58156-046, A58156-047, A58156-048, A59343-035, A59160-025, A59269-011, A59343-036, A59343-037, A58988-036, A59160-023, A59160-026, A59154-036, A59154-037, A59160-039, A59343-022, A59343-023, A58821-043, A58821-044, A58821-045, A58821-046, A58821-047, A58988-038, A58988-039, A59154-047, A59154-048, A59160-021, A59160-022, A59160-027, A59160-028, A59160-038, A59160-045, A59343-038, A59343-039, A59343-040, A59343-041, A59343-042, A58988-016, A58988-017; b) T42280, GTIN 00643169123083, Serial Numbers: A58840-084, A58489-021, A57660-021, A58489-023, A58489-024, A58812-035, A58812-038, A58582-011, A58264-023, A58264-024, A58264-025, A58264-011, A58264-012, A58489-017, A58489-018, A58840-087, A58489-011, A58085-011, A58840-091, A58812-031, A58840-088, A58840-086, A58812-041, A58812-042, A58812-032, A58812-033, A58812-034, A58840-080, A57660-011, A57660-012, A57660-013, A57660-014, A57660-017, A57660-018, A58264-013, A58812-045, A58840-076, A58840-077, A58840-078, A57660-019, A57660-020, A58840-082, A58489-022, A57660-015, A57660-016, A58812-039, A58840-079, A58840-085, A58264-014, A58489-020, A58812-037, A58812-043, A58812-044, A58840-081, A58840-083, A58812-040, A58489-019, A58812-036, A58840-089, A58264-015, A58264-016, A58264-017, A58264-018, A58264-019, A58264-020, A58489-012, A58489-013, A58489-014, A58264-021, A58264-022