Centinel Spine, Inc.
Complete recall history across all FDA and CPSC categories — 4 total recalls
Centinel Spine, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (4)
FDA medical device enforcement actions by Centinel Spine, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cer... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm produc... | Class II |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical di... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm produc... | Class II |
| Dec 31, 2025 | Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 ... | Products were mislabeled as the 6mm product but included the 5 mm product. | Class II |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 | During the assembly of Prodisc C, a blue discoloration was observed on a Prod... | Class II |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog... | During the assembly of Prodisc C, a blue discoloration was observed on a Prod... | Class II |
| Mar 5, 2021 | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in ske... | Centinel Spine learned through five customer complaints that the product was ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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