Medtronic Sofamor Danek USA Inc: Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 E

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: 19057 units Lot/code info: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200, GTIN 00613994960955, Serial Numbers: A40821, A41333, A42693, A42811, A43336, A43592, A44884, A44960; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210, GTIN 00613994960948, Serial Numbers: A42415, A42482, A42953, A43212, A43354, A43965, A44760, A45028, A46673, A48105, A48484, A49062, A49564, A50856, A52420, A52719, A52904, A53373; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200, GTIN 00643169123052, Serial Numbers: A38910-046, A38910-047, A38910-048, A38910-049, A38910-050, A38910-051, A38910-052, A38910-053, A38910-054, A38910-055, A38910-056, A38910-057, A39374-061, A39374-062, A39374-063, A39374-064, A39374-065, A39374-066, A39374-067, A39374-068, A39374-069, A39374-070, A39374-071, A39374-072, A39736-021, A39736-022, A39736-023, A39736-024, A39736-025, A39736-026, A39736-027, A39736-028, A39736-029, A39736-030, A39736-031, A39736-032, A39803-051, A39803-052, A39803-053, A39803-054, A39803-055, A39803-056, A39803-057, A39803-058, A39803-059, A39803-060, A39803-061, A39803-062, A40169-050, A40169-051, A40169-052, A40169-053, A40169-054, A40169-055, A40169-056, A40169-057, A40327-056, A40327-057, A40327-058, A40327-059, A40327-060, A40327-061, A40327-062, A40327-063, A40656-036, A40656-037, A40656-038, A40656-039, A40656-040, A40656-042, A40656-043, A40656-044, A40656-045, A40656-046, A40656-047, A40710-051, A40710-052, A40710-053, A40710-054, A40710-055, A40710-056, A40710-057, A40710-058, A40710-059, A40

UPC codes

00613994960955, 00613994960948, 00643169123052

Source

Official record: FDA (Device enforcement) ↗

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