Z-1265-2015Class II

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...

Name: Z-1265-2015 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...
Creator: Southern Implants, Inc
Published: 2015-01-23
License: https://open.fda.gov/license/

Southern Implants, (Pty.) Ltd. / initiated 2015-01-23 / Terminated / root cause: labeling and UDI

FDA source

Southern Implants, Inc began a recall of 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... on 2015-01-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1265-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Posted: 2015-03-12
Terminated: 2015-05-20
Recalling firm: Southern Implants, (Pty.) Ltd.
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.
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: A customer notification letter dated 1/23/15 was sent to customers to inform them that Southern Implant is recalling the MAX-TL 9.0x7.0mm Implant because it may contain a Z-MAX9-7 Implant, 9mm diameter, 7mm length. Customers are instructed to return the fax back form and to contact customer relations depart at (866) 902-9272.
Quantity in commerce: 130 units
Distribution: US Nationwide Distribution.
Product codes and lots: MAX-TL Lot# 1244041400 Z-MAX9-7 Lot# 1238041402

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1265-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1265-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-11

Product code DZE

K071161Class IIEndosseous Dental Implant SystemSouthern Implants, Inc. / cleared 2007-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)