Osteotec Limited

FDA Regulatory Profile

Osteotec Limited appears in FDA public data with 1 recall, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2222-2025, Class II) was initiated on June 18, 2025.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2222-2025Class IIBrand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (June 18, 2025