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Recall Observatory FDA recall evidence

Device product

Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

Z-0401-2022

December 03, 2021

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 89086
Status
Ongoing
Classification
Class II
Quantity
22 units
Official record key
device-enforcement:Z-0401-2022

Official wording

Reason: Incorrect product is contained in the packaging.

Code information: Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect product is contained in the packaging.