West Chester, PA, United States
Centinel Spine, Inc. recalls
4 recalls recorded since 2018, most recently on 20 March 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 March 2026
- 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.
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2050-2026, Z-2051-2026
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Ongoing Class II Medical devices
- Recall started
- 31 December 2025
- Reason
- Products were mislabeled as the 6mm product but included the 5 mm product.
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1426-2026
- Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Ongoing Class II Medical devices
- Recall started
- 18 July 2024
- Reason
- During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3212-2024, Z-3213-2024
- prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
- prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Terminated Class II Medical devices
- Recall started
- 5 March 2021
- Terminated
- 2 August 2021
- Reason
- Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.
- Distribution
- US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1406-2021
- Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc d
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.