Cervical disc replacement recalled for foreign contamination in assembly
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical implant with detected foreign contamination. The contamination was not fully evaluated per manufacturing standards, creating a risk of device failure or patient harm. However, no illnesses or injuries have been reported, placing this in the High rather than Severe category per the rubric.
Plain-English summary
Centinel Spine, Inc. is recalling the Prodisc C SK total cervical disc replacement device (Model PDSM5). The recall involves 12 units distributed nationwide in the United States.
During assembly, a blue discoloration was observed on the inlay. The manufacturer considers this discoloration a foreign contaminant that was not fully evaluated in manufacturing validation procedures.
Patients who have received this device or healthcare providers with units in inventory should contact Centinel Spine, Inc. immediately for guidance on appropriate action.
The recalled product
- Product
- prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
- Manufacturer
- Centinel Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 00843193113856
- Lot 2024-0482
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Centinel Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Centinel Spine, Inc.
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Similar recalls
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FDA (Devices) · 2026-02-25
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