Centinel Spine, Inc.: Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

Recall number

Z-1426-2026

Recalling firm

Centinel Spine, Inc.

Product

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

Status

Open, Classified

Initiated

2025-12-31

Posted

2026-02-17

Terminated

not on file

Reason

Products were mislabeled as the 6mm product but included the 5 mm product.

Root cause

Process control

Action

On or around December 31, 2025 Phone calls were made to customers to notify them of the recall. Follow-up URGENT PRODISC C SK US IMPLANT LARGE 6MM DEVICE RECALL letters were also emailed to customers. Actions to be taken: We request that you review your inventory and return any units in your possession of this impacted lot number. We recommend monitoring any patient that has received the recalled device for any unexpected device-related symptoms throughout the regularly scheduled check-in procedures. Actions to Be Taken by Centinel Spine: Centinel Spine intends to remove all remaining implants effected by this recall from the market and issue a replacement product with corrected labeling for any remaining products in the Distributors possession that are subject to this recall.

Quantity

20 units

Distribution

US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.

Lot, serial or model codes

Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

510(k) numbers

not on file

PMA numbers

["P070001","P070001S019","P070001S025"]

Product code

MJO

Firm FEI

3007494564

Firm city

West Chester

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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