- Recalling firm
- XTANT Medical Holdings, Inc
- Reason for recall
- Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
- Affected products (lot / model / serial)
- Part #: 90-300-251008 UDI-DI 00849777012478 Lot #(s): 385486-RP25-0080 387070-RP25-0081 415971-RP25-0077 436563-RP25-0082 436564-RP25-0079 436565-RP25-0076 444927-RP25-0078 Part #: 90-300-25508 UDI-DI 00849777012492 Lot #(s): 387071-RP25-0083 418098-RP25-0084 436199-RP25-0085 Part #: 90-300-251004 UDI-DI 00849777012461 Lot #(s): 401347-RP25-0070 415871-RP25-0073 415872-RP25-0074 416678-RP25-0072 416679-RP25-0071 418509-RP25-0075 Part #: 90-400-25508 UDI-DI 00849777012539 Lot #(s): 445442-RP25-0128
- Units affected
- 225
- Distribution pattern
- US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
- Firm location
- Belgrade, MT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1897-2026
- Recall initiated
- March 9, 2026
- FDA classification date
- April 21, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98643
- Last updated on HTM Vibe
- July 24, 2026