Signature Orthopedics Pty Limited

FDA Regulatory Profile

Signature Orthopedics Pty Limited appears in FDA public data with 4 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1694-2021, Class II) was initiated on April 20, 2021.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1694-2021Class IILogical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient toApril 20, 2021
Z-0833-2019Class IIGenius Knee Cemented Tibial Component Product Usage: Knee replacement componentDecember 10, 2018
Z-0834-2019Class IIGenius Knee Cemented CR Femoral Component Product Usage: Knee replacement componentDecember 10, 2018
Z-0920-2018Class IISignature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are February 2, 2018