Cervical disc implants recalled after 5mm product was labeled 6mm
Centinel Spine is recalling 20 Prodisc C SK total cervical disc replacements because products were mislabeled as the 6mm product but included the 5mm product.
What this means for you
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: Scored 3 under the risk-of-harm criterion: a cervical disc implant labeled as a different size than its contents could be implanted in error, and no injuries are reported.
Plain-English summary
The Prodisc C SK, model/catalog number PDSL6, a total cervical disc replacement, is being recalled by Centinel Spine, Inc.
The reason given in the enforcement record is that products were mislabeled as the 6mm product but included the 5mm product.
The record lists 20 units. Distribution was nationwide in the United States, in Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee and Texas. The FDA has classified the action as Class II.
An implant of a different height than its label states may not match what the surgeon selected. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Centinel Spine's instructions.
The recalled product
- 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
- Manufacturer
- Centinel Spine, Inc.
- Category
- Medical Device — Spinal implant
- Affected units
- 20
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 (3)
- Model Number: PDSL6
- UDI-DI 00843193113924
- Lot 2025-0776
Distribution
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