RegWardenFDA facility compliance records
Facility

implantcast GmbH

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

Activity by year

FDA actions on record by year2017: 1 recalls; 2021: 1 recalls120172018201920201202120222023202420252026
  • Recalls (2)

Devices registered here (2)

  • Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
    Product code OQI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3353
  • Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
    Product code LZO (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3353

Recalls & enforcement

  • Class IITerminated2021-05-10
    A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the q…
  • Class IITerminated2017-12-28
    Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.

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. “implantcast GmbH (FEI 3012523063) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012523063-implantcast-gmbh/

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