RegWardenFDA facility compliance records
Company

LinkBio Corp.

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2023: 2 recalls; 2026: 1 recalls201720182019202020212022220232024202512026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-03-12
    The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
  • Class IIOngoing2023-04-25
    Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
  • Class IIOngoing2023-03-21
    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique l…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “LinkBio Corp. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10022893-linkbio-corp/

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