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Centinel Spine, Inc. recalls prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Recalled October 2, 2024 · FDA recall Z-3212-2024 · Centinel Spine
Hazard
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations. · FDA Class II
Units
12 units
Sold at
US Nationwide distribution.
Description
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Manufacturer(s)
Centinel Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →