Medtronic Sofamor Danek USA Inc: Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; 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: 430 units Lot/code info: 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, A58789-05

UPC codes

00643169965058, 00643169122918, 00643169122925, 00643169122932

Source

Official record: FDA (Device enforcement) ↗

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