UnratedMedical device recall · FDA · Published July 18, 2024
Centinel Spine Prodisc C SK Recall: Blue Discoloration Risk
Centinel Spine recalls Prodisc C SK cervical disc replacements with possible blue discoloration indicating foreign contamination. Affected units have model PDSM5 and lot 2024-0482. No remedy specified in official notice.
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.
Take action
Contact the company
📍Recalling firmCentinel Spine, Inc.900 Airport Rd Ste 3b · West Chester, PA 19380-3416
“Centinel Spine Prodisc C SK Recall: Blue Discoloration Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54591-centinel-spine-prodisc-c-sk-recall-blue-discoloration-risk. Based on FDA recall #Z-3212-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3212-2024%22&limit=1).
The FDA announced on July 18, 2024, that Centinel Spine is recalling the prodisc C SK total cervical disc replacement medical device due to a foreign contaminant. The hazard involves a blue discoloration observed during assembly that may not have been fully evaluated in manufacturing validations.
How to tell if you have it
Brand: Centinel Spine
Product: prodisc C SK, Total cervical disc replacement
Model/Catalog Number: PDSM5
UDI-DI: 00843193113856
Lot Code: 2024-0482
Units Affected: 12 units
The hazard
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.
Context
GovInfoNow's records show Centinel Spine has issued three other recalls since March 5, 2021, including labeling mix-ups reported on Dec. 31, 2025, and March 20, 2026. Other recent recalls of similar products include the Fresenius Medical Care Citrasate Liquid Acid Concentrate Recall (July 14, 2026) and the B Braun Spinocan Spinal Needle Kits Recall (May 6, 2026).
How to tell if you have this one
Check for model number PDSM5 and lot number 2024-0482 on the device. The product is a cervical disc replacement used in spinal surgery.
Brand
Centinel Spine
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-3212-2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5; UDI-DI 00843193113856; Lot 2024-0482
12 units
Z-3213-2024
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5; Lot Code: UDI-DI 00843193113856; Lot 2024-0482
6 units
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for model number PDSM5 and lot number 2024-0482 on the Prodisc C SK device.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3212-2024 (July 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3212-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.