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U.S. Department of Health and Human Services

Class 2 Device Recall Max Implant

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 Class 2 Device Recall Max Implantsee related information
Date Initiated by FirmJanuary 23, 2015
Date PostedMarch 12, 2015
Recall Status1 Terminated 3 on May 20, 2015
Recall NumberZ-1265-2015
Recall Event ID 70524
510(K)NumberK071161 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductMAX-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
ActionA 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 Commerce130 units
DistributionUS Nationwide Distribution.
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = DZE
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