MAX-TL 9 — Class II medical device recall Z-1265-2015
Terminated recall by Southern Implants, Inc, reported 2015-03-18, distributed nationwide. Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant,
| Recall number | Z-1265-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southern Implants, Inc, Irvine, CA, United States |
| Recall initiated | 2015-01-23 |
| Classified | 2015-03-11 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2015-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 130 units |
| Reason classes | labeling |
| Lot numbers | 1238041402, 1244041400, Z-MAX9-7 |
| Model numbers | 15711K, Z-MAX9-7 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1265-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.