Reported Nov 18, 2020 · Terminated
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following…
XTANT Medical
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XTANT Medical · 664 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
24 of 24 products
| Model / number | Product as published |
|---|---|
| — | Reference numbers/ Primary DI Number/Material Grade on Label |
X098-0106-STR | DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3 |
X098-0107-STR | DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4 |
X098-0108-STR | DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5 |
X098-0109-STR | DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6 |
X098-0110-STR | DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7 |
X098-0111-STR | DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8 |
X098-0112-STR | DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9 |
X098-0205-STR | DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10 |
X098-0206-STR | DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11 |
X098-0207-STR | DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12 |
X098-0208-STR | DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13 |
X098-0209-STR | DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14 |
X098-0210-STR | DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15 |
X098-0211-STR | DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16 |
X098-0212-STR | DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17 |
X098-0305-STR | DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18 |
X098-0306-STR | DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19 |
X098-0307-STR | DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20 |
X098-0308-STR | DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21 |
- Lot codes and dates
- Reference
- Number/Lot Number/Expiration dateX098-0106-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
- Amount recalled
- 508 units
Where it was sold
Why it was recalled
Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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