Cervical disc implant recalled due to foreign contamination during assembly
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination 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 a Class II FDA recall of an implanted cervical disc with a documented manufacturing defect (foreign contamination on the inlay). No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Centinel Spine, Inc. is recalling the Prodisc C SK (Model PDSM5), a total cervical disc replacement implant. Six units were distributed nationwide in the United States.
During assembly of the devices, blue discoloration was observed on the product's inlay. This discoloration is classified as a foreign contaminant. The discoloration was not fully evaluated during manufacturing validation, creating uncertainty about its potential impact on device safety or performance.
For additional information, healthcare providers and patients should contact Centinel Spine, Inc. or the U.S. Food and Drug Administration. The FDA recall number is Z-3213-2024.
The recalled product
- Product
- prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
- Manufacturer
- Centinel Spine, Inc.
- Affected units
- 6
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)
- Lot Code: 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
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