Medtronic Sofamor Danek USA Inc: Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CM

Hazard

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Details from the source

Reason for recall: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Om Quantity: 23850 units Lot/code info: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275, GTIN 00613994960931, Serial Numbers: A42914, A43126, A43182, A43185, A43460, A43613, A43715, A43896, A44262, A44388, A44561, A45997, A46401, A46690, A46699, A47001, A47719, A47942, A48136, A48371, A48792, A49045, A49089, A49108, A49790, A49952, A50039, A50528, A50688, A51827, A52539, A52601, A52788, A53401, A53671, A53788, A53881, A53904, A54204, A54988, A55032, A55132; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280, GTIN 00613994960924, Serial Numbers: A42850, A43731, A44343, A44529, A44821, A45022, A45035, A46734, A47604, A47621, A47701, A47971, A48051, A48578, A49616, A51011, A52580, A52809, A54208, A54369, A54440, A54597, A55584; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275, GTIN 00643169123076, Serial Numbers: A39563-061, A39563-062, A39563-063, A39563-064, A39563-065, A39563-066, A39563-068, A39563-070, A39563-071, A39563-072, A39563-073, A39563-074, A39563-075, A39563-076, A39563-077, A40837-011, A41106-011, A41106-012, A41106-013, A41106-014, A41106-015, A41106-016, A41106-017, A41106-018, A41106-019, A41558-011, A41558-012, A41558-013, A41558-014, A41558-015, A41558-016, A41656-011, A41656-012, A41656-013, A41656-014, A41656-015, A41656-016, A41656-017, A41656-018, A41656-019, A41656-020, A41656-021, A41656-022, A41656-023, A41656-024, A41656-025, A41656-026, A41656-027, A41656-028, A41656-029, A41656-030, A41656-031, A41656-032, A41656-033, A41656-034, A41656-035, A41656-036, A41656-037, A41

UPC codes

00613994960931, 00613994960924, 00643169123076

Source

Official record: FDA (Device enforcement) ↗

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