Theken Companies LLC
Theken Companies LLC appears in FDA public data with 1 recall, 5 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0227-2026, Class II) was initiated on September 11, 2025. Its most recent 510(k) clearance was granted on September 30, 2022.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0227-2026 | Class II | iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Asse | September 11, 2025 |