medical Class III Updated 2020-11-18

XTANT Medical recalls XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged

Recalled Product

XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25


Hazard / Issue

Cervical Implants contain a label that incorrectly identifies the grade of titanium used.

Issued by

FDA

Affected States: FL, TX, CA, OH, AZ
Lot/Code Info: Reference Number/Lot Number/Expiration date: X098-0106-STR/ 1220190000207152/ 12-13-24, X098-0107-STR / 1220190000207153/ 12-06-24, X098-0108-STR / 1220190000207154/ 12-06-24, X098-0109-STR / 0120200000207155 / 01-10-25, X098-0110-STR / 0120200000207156 / 01-10-25, X098-0111-STR / 0120200000207157 / 01-10-25, X098-0112-STR / 1220190000207158 / 12-07-24, X098-0205-STR / 1220190000207159 / 12-06-24, X098-0206-STR / 12201900002071510 / 12-06-24, X098-0207-STR / 12201900002071511 / 12-07-24, X098-0208-STR / 12201900002071512 / 12-07-24, X098-0209-STR / 12201900002071513 / 12-06-24, X098-0210-STR / 12201900002071514 / 12-07-24, X098-0211-STR / 12201900002071515 / 12-07-24, X098-0212-STR / 12201900002071516 / 12-07-24, X098-0305-STR / 02202000002071517 / 02-05-25 X098-0306-STR / 12201900002071518 / 12/13/24, X098-0307-STR / 01202000002071519 / 01-10-25, X098-0308-STR / 12201900002071520 / 1213-24, X098-0309-STR / 12201900002071521 / 12-07-24, X098-0310-STR / 12201900002071522 / 12-07-24, X098-0311-STR / 12201900002071523 / / 12-07-24, X098-0312-STR / 12201900002071524 / 12-08/24
View official government recall

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