Centinel Spine Recalls Prodisc C Devices Missing Orientation Marking
Centinel Spine is recalling 49 Prodisc C cervical disc prostheses because the 'UP' orientation marking is missing from the superior plate.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a missing orientation marking, which is a labeling/defect issue that could lead to improper placement, but the source notes that other orientation guides were present and no injuries are reported.
Plain-English summary
Centinel Spine, Inc. is recalling 49 units of the Prodisc C prosthesis, an intervertebral disc device indicated for skeletally mature patients with intractable symptomatic cervical disc disease. The recall was initiated after the company received five customer complaints indicating that the 'UP' etching was missing from the superior plate of the device.
The 'UP' marking is one of the methods used to indicate the direction in which the surgeon should place the Prodisc C into the intradiscal space. According to the source text, additional 'UP' indications were present on the packaging and instrumentation to help guide proper implantation. The affected devices were distributed nationwide in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, and MI.
The specific lot number for the recalled devices is 2020-0600. Consumers and healthcare providers should verify the lot number and UDI (01)00843193112842(17)241231(10)2020-0600) of any Prodisc C devices in their possession to determine if they are affected by this recall.
The recalled product
- Product
- Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
- Manufacturer
- Centinel Spine, Inc.
- Affected units
- 49
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 (1)
- UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600
Distribution
Related recalls
Same manufacturer · Centinel Spine, Inc.
See all →- HighProdisc C SK Cervical Implant Size Labeling Mix-Up Recall
FDA (Devices) · 2026-05-13
- HighProdisc C SK cervical disc implant labeling mix-up recalled
FDA (Devices) · 2026-05-13
- HighCervical disc implants recalled after 5mm product was labeled 6mm
FDA (Devices) · 2026-02-25
- HighCervical disc implant recalled due to foreign contamination during assembly
FDA (Devices) · 2024-10-02
- HighCervical disc replacement recalled for foreign contamination in assembly
FDA (Devices) · 2024-10-02
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02