aap Implantate AG
Country not established FDA
- Devices
- 3,940
- Registrations
- FDA
- FDA recalls
- 4
What aap Implantate AG makes
The company manufactures orthopaedic fixation hardware, including non-bioabsorbable plates, non-sliding bone screws, and implantable bone washers. It also produces reusable surgical tools such as drill guides, depth gauges, instrument trays, and aiming/guiding attachments, alongside implant racks for organized storage. These products are designed for use in orthopaedic procedures requiring precise fixation and instrument organization.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
Catalogue
Search and filter all 3,940 devicesShowing 1,951-2,000 of 3,940
Company details
- DUNS number
- 328420633
- [email protected]
- Phone
- +4930750190
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 4
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 28 Nov 2019 Z-1675-2020 Class II Terminated 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.
- 25 Jan 2019 Z-0731-2020 Class III Terminated Products were distributed with the incorrect instructions for use.
- 25 Jan 2019 Z-0732-2020 Class III Terminated Products were distributed with the incorrect instructions for use.
- 11 Jan 2019 Z-1019-2019 Class II Terminated There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
FDA establishments
- Aap Implantate AG BERLIN · DE FEI 3001406084
Frequently asked questions
How many devices does aap Implantate AG have in the registry?
The registry currently lists 3940 devices for aap Implantate AG. Devices recorded under merged duplicate company entries are counted once.
Are there FDA recall records for aap Implantate AG?
FDA recall records list 4 recalls initiated by aap Implantate AG, the most recent initiated on 28 Nov 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
Which FDA establishments are linked to aap Implantate AG?
1 FDA establishment is linked to aap Implantate AG in the registry; they are listed on the company page.