CORENTEC CO., LTD.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (2)
Devices registered here (1)
- ImpactorProduct code HWA (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540
Recalls & enforcement
- Class IIOngoing2024-03-29Due to unsupported 10 year expiration date.
- Class IITerminated2017-02-27Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
FDA inspections (2)
- VAI2024-08-29Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- VAI2019-10-31Voluntary Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “CORENTEC CO., LTD. (FEI 3009106092) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009106092-corentec-co-ltd/
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