RegWardenFDA facility compliance records
Facility

SOUTHERN IMPLANTS (PTY) LTD

3 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2016: 1 inspections; 2018: 1 recalls1’13’141’151’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (3)
  • Inspections (1)

Devices registered here (1)

  • Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
    Product code KCT (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6850

Recalls & enforcement

  • Class IITerminated2018-03-08
    The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
  • Class IITerminated2015-01-23
    Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.
  • Class IITerminated2013-09-13
    Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-5…

FDA inspections (1)

  • NAI2016-01-28
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SOUTHERN IMPLANTS (PTY) LTD (FEI 3003394627) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003394627-southern-implants-pty-ltd/

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