Date Initiated by Firm |
January 23, 2015 |
Date Posted |
March 12, 2015 |
Recall Status1 |
Terminated 3 on May 20, 2015 |
Recall Number |
Z-1265-2015 |
Recall Event ID |
70524 |
510(K)Number |
K071161
|
Product Classification |
Implant, endosseous, root-form - Product Code DZE
|
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. |
Code Information |
MAX-TL Lot# 1244041400 Z-MAX9-7 Lot# 1238041402 |
Recalling Firm/ Manufacturer |
Southern Implants, Inc 5 Holland Ste 209 Irvine CA 92618-2576
|
For Additional Information Contact |
949-273-8505
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = SOUTHERN IMPLANTS, INC.
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