AAP Implantate Ag
FDA Regulatory Profile
AAP Implantate Ag appears in FDA public data with 4 recalls, 37 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1675-2020, Class II) was initiated on November 28, 2019. Its most recent 510(k) clearance was granted on March 24, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 37
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1675-2020 | Class II | aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 | November 28, 2019 |
| Z-0731-2020 | Class III | INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 | January 25, 2019 |
| Z-0732-2020 | Class III | INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425 | January 25, 2019 |
| Z-1019-2019 | Class II | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are | January 11, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | March 24, 2026 |
| K233008 | Cannulated Headless Bone Screws | June 5, 2024 |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | March 17, 2023 |
| K211582 | LOQTEQ Proximal Humerus Plate 3.5 System | October 18, 2021 |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | March 3, 2021 |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | August 1, 2019 |
| K182785 | LOQTEQ VA Foot Plates 2.5 | June 19, 2019 |
| K161696 | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 | November 23, 2016 |
| K161747 | LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal An | November 22, 2016 |
| K161703 | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer | November 4, 2016 |
| K153034 | aap LOQTEQ VA Radius Set 2.5 | January 21, 2016 |
| K150974 | aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium | April 29, 2015 |
| K141949 | CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM | September 12, 2014 |
| K141823 | AAP LOQTEC CLAVICLE PLATES 2.7/3.5 | August 7, 2014 |
| K140607 | AAP LOQTEC(R) OLECRANON PLATE | May 8, 2014 |
| K133675 | AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 | January 23, 2014 |
| K132787 | LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE | December 24, 2013 |
| K131782 | LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 | November 18, 2013 |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | October 17, 2013 |
| K132554 | AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 | October 3, 2013 |