Berlin, N/A, Germany
AAP Implantate Ag recalls
3 recalls recorded since 2018, most recently on 28 November 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 November 2019
- Terminated
- 27 March 2025
- Reason
- 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.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1675-2020
- aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Terminated Class III Medical devices
- Recall started
- 25 January 2019
- Terminated
- 30 September 2024
- Reason
- Products were distributed with the incorrect instructions for use.
- Distribution
- Texas
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0731-2020, Z-0732-2020
- INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
- INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Terminated Class II Medical devices
- Recall started
- 11 January 2019
- Terminated
- 26 May 2022
- Reason
- There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
- Distribution
- Worldwide Distribution - US Nationwide in the state of Texas and country of Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1019-2019
- aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surger
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.