Southern Implants, (Pty.) Ltd.

FDA Regulatory Profile

Southern Implants, (Pty.) Ltd. appears in FDA public data with 1 recall, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1386-2018, Class II) was initiated on March 8, 2018.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Known Names

southern implants, (pty.), southern implants (pty)

Recent Recalls

NumberClassProductDate
Z-1386-2018Class IISOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical plMarch 8, 2018