Centinel Spine, Inc.: Prosthesis, Intervertebral Disc
Recall Summary Centinel Spine is recalling Prodisc C SK cervical disc replacement implants (Model PDSXL6, 6mm size) distributed nationwide because the packaging labels are incorrect—the 6mm implants are labeled as 5mm, and 5mm implants are labeled as 6mm. This labeling mix-up could result in surgeons implanting the wrong-sized disc during cervical spine procedures. The recalled products were distributed across multiple states including Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee, and Texas.
- Recalling firm
- Centinel Spine, Inc.
- Product
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
- Reason
- 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.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4a31c0f3-6cc1-415b-ab6e-469feded120c