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Recall Observatory FDA recall evidence

Device product

Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

Z-2753-2016

June 20, 2016

Class II

Product summary

Firm
Anthogyr
Event
Event 74722
Status
Terminated
Classification
Class II
Quantity
111 units
Official record key
device-enforcement:Z-2753-2016

Official wording

Reason: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.

Code information: Code OP34080 Size 03.4 x 8.0 Code OP34100 Size 03.4 x 10.0 Code OP34120 Size 03.4 x 12.0 Code OP34140 Size 03.4 x 14.0 Code OP34160 Size 03.4 x 16.0 Code OP34180 Size 03.4 x 18.0 Code OP40060 Size 04.0 x 6.5 Code OP40080 Size 04.0 x 8.0 Code OP40100 Size 04.0 x 10.0 Code OP40120 Size 04.0 x 12.0 Code OP40140 Size 04.0 x 14.0 Code OP40160 Size 04.0 x 16.0 Code OP40180 Size 04.0 x 18.0 Code OP46060 Size 04.6 x 6.5 Code OP46080 Size 04.6 x 8.0 Code OP46100 Size 04.6 x 10 Code OP46120 Size 04.6 x 12 Code OP46140 Size 04.6 x 14 Code OP52060 Size 05.2 x 6.5 Code OP52080 Size 05.2 x 8.0 Code OP52100 Size 05.2 x 10.0 Code OP52120 Size 05.2 x 12.0 Code OP52140 Size 05.2 x 14.0

Distribution pattern: US Distribution to sates of: NC, NY, and OR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Following a FDA inspection showing that the firm failed to validate the design and process of its implants.