Facility

AAP IMPLANTATE AG

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

Key facts

3recalls · worst Class II

4inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3001406084
Establishment type	Manufacture Medical Device
Location	LORENZWEG 5 BERLIN, DE 12099
Registration status	Active · expires 2026
Parent company	AAP IMPLANTATE AG (owner-operator 9004207)
Brand names	Cannulated Screws 2

Activity by year

Recalls (3)
Inspections (4)

Devices registered here (2)

Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040
Washer, Bolt Nut
Product code HTN (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

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.

FDA inspections (4)

NAI2025-09-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2022-11-04
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2019-11-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-05-17
No 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.

All facilities operated by AAP IMPLANTATE AG

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. “AAP IMPLANTATE AG (FEI 3001406084) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001406084-aap-implantate-ag/

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