Class II — Southern Implants, Inc
| Recalling firm | SOUTHERN IMPLANTS (PTY) LTD |
|---|---|
| Registered facility | SOUTHERN IMPLANTS (PTY) LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. |
| Quantity | 130 units |
| Distribution | US Nationwide Distribution. |
| Initiated | 2015-01-23 |
| Classified | 2015-03-11 |
| Terminated | 2015-05-20 |
| Recall number | Z-1265-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Southern Implants, Inc (Z-1265-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70524/
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