- Recalling firm
- Centinel Spine, Inc.
- Reason for recall
- Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
- Affected products (lot / model / serial)
- Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027
- Units affected
- 30 units
- Distribution pattern
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
- Firm location
- West Chester, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2051-2026
- Recall initiated
- March 20, 2026
- FDA classification date
- May 1, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98721
- Last updated on HTM Vibe
- July 24, 2026