Medtronic Sofamor Danek USA Inc: Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; 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: 282 units 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,

UPC codes

00643169123076, 00643169123083

Source

Official record: FDA (Device enforcement) ↗

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