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Recall Observatory FDA recall evidence

Device 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.

Z-1265-2015

January 23, 2015

Class II

Product summary

Firm
Southern Implants, Inc
Event
Event 70524
Status
Terminated
Classification
Class II
Quantity
130 units
Official record key
device-enforcement:Z-1265-2015

Official wording

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.

Code information: MAX-TL Lot# 1244041400 Z-MAX9-7 Lot# 1238041402

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.