Medtronic Sofamor Danek USA Inc: Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Agency Publication Date: April 19, 2023

Affected Products

Product: INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

GTIN 00643169554689, Lot/Batch numbers: H5802983

Lot Numbers:

numbers

Product: INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

GTIN 00643169541856, Lot/Batch numbers: H5802984

Lot Numbers:

numbers

Product: INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

GTIN 00643169552654, Lot/Batch numbers: H5806333

Lot Numbers:

numbers

Product: INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

GTIN 00643169554696, Lot/Batch numbers: H5806345

Lot Numbers:

numbers

Product: INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

GTIN 00643169554696, Lot/Batch numbers: H5806345

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91790

Status: Active

Manufacturer: Medtronic Sofamor Danek USA Inc

Manufactured In: United States

Units Affected: 5 products (45 units; 10 units; 2 units; 90 units; 13 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

GTIN 00643169554689, Lot/Batch numbers: H5802983

Lot Numbers:

numbers

GTIN 00643169541856, Lot/Batch numbers: H5802984

Lot Numbers:

numbers

GTIN 00643169552654, Lot/Batch numbers: H5806333

Lot Numbers:

numbers

GTIN 00643169554696, Lot/Batch numbers: H5806345

Lot Numbers:

numbers

GTIN 00643169554696, Lot/Batch numbers: H5806345

Lot Numbers:

numbers