Medtronic Sofamor Danek USA Inc: Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRA

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: 2987 units Lot/code info: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A44616-020, A44616-021, A44616-022, A44616-023, A44616-024, A44616-025, A44616-026, A44616-027, A44616-028, A44616-029, A44616-030, A44616-031, A44616-032, A44616-033, A44616-034, A44616-035, A44704-011, A44704-012, A44704-013, A44704-014, A44704-015, A44704-016, A44704-017, A44704-018, A44704-019, A44704-020, A44704-021, A44704-022, A44704-023, A44704-024, A45275-011, A45275-012, A45275-013, A45275-014, A45275-015, A45275-016, A45275-017, A45275-018, A45275-019, A45275-020, A45275-021, A45275-022,

UPC codes

00613994961006, 00643169122994, 00643169964877, 00643169123007, 00643169430969, 00643169964884, 00643169123014

Source

Official record: FDA (Device enforcement) ↗

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