XTANT Medical recall
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI…
Why was XTANT Medical recalled?
Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- XTANT Medical
- Quantity
- 508 units
- Distribution
- US: FL, TX, CA, OH, AZ, OH OUS: None
- Recall date
- November 18, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)