XTANT Medical Recalls Cervical Implants Due to Incorrect Titanium Grade Labeling
XTANT Medical is recalling 508 units of cervical implants because the labels incorrectly identify the grade of titanium used in the devices.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding material grade, not a functional defect or contamination.
Plain-English summary
XTANT Medical is recalling 508 units of cervical implants. The recall is due to a labeling error where the product labels incorrectly identify the grade of titanium used in the devices.
The affected products are sterile, single-use cervical implants packaged in Tice-C. The recall covers specific reference numbers, lot numbers, and expiration dates ranging from December 2024 to February 2025. The devices are made of commercially pure titanium in various grades (Grade 3 through Grade 25).
The recalled products were distributed in the United States to Florida, Texas, California, Ohio, and Arizona. No international distribution is reported. Consumers and healthcare providers should stop using these specific units and contact XTANT Medical for further instructions.
The recalled product
- 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…
- Manufacturer
- XTANT Medical
- Hazard
- Affected units
- 508
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- X098-0307-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
Distribution
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