Events

Recall of Device Recall Max Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southern Implants, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70524
  • Event Risk Class
    Class 2
  • Event Number
    Z-1265-2015
  • Event Initiated Date
    2015-01-23
  • Event Date Posted
    2015-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133979
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, endosseous, root-form - Product Code DZE
  • 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.
  • 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.

Device

Device Recall Max Implant
  • Model / Serial
    MAX-TL Lot# 1244041400  Z-MAX9-7 Lot# 1238041402
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • 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.
  • Manufacturer
    Southern Implants, Inc

Manufacturer

Southern Implants, Inc
  • Manufacturer Address
    Southern Implants, Inc, 5 Holland Ste 209, Irvine CA 92618-2576
  • Manufacturer Parent Company (2017)
    Southern Implants Inc.
  • Source
    USFDA