Recall Z-1265-2015— Southern Implants, Inc

Name: FDA recall Z-1265-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-23

Class II · Terminated

Class II FDA medical device recall by Southern Implants, Inc, initiated 2015-01-23, terminated 2015-05-20. It names one FDA 510(k) clearance: K071161. 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: 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..

Recalling firm: Southern Implants, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Terminated: 2015-05-20
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071161 — ENDOSSEOUS DENTAL IMPLANT SYSTEMSouthern Implants, Inc.·cleared 2007-11-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.