RegWardenFDA facility compliance records
Company

AAP IMPLANTATE AG

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

Recalls by year

FDA actions on record by year2019: 3 recalls20172018320192020202120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2019-11-28
    The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
  • Class IIITerminated2019-01-25
    Products were distributed with the incorrect instructions for use.
  • Class IITerminated2019-01-11
    There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.

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. “AAP IMPLANTATE AG — 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-9004207-aap-implantate-ag/

Not open yet

Alerts for AAP IMPLANTATE AG

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.