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Open, Classified

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

FDA Recall Z-0401-2022 · Posted None

Recalling FirmWright Medical Technology, Inc.
Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2021-12-03
Product Quantity22 units

Reason for Recall

Incorrect product is contained in the packaging.

Firm Action

The recalling firm issued a recall letter dated 03 Dec 2021 on 12/3/2021 via Fed Ex Priority Overnight. The letter explained the packages contain the incorrect screws, provides potential risks and the actions needed to be taken. The consignee is to immediately check their inventory to locate the packaged product and remove them from their point of use. The enclosed business reply form was to be returned via email to confirm receipt of the letter and document product segregation. After the firm receives the reply form, the consignee will be contacted to arrange for return and replacement. The consignee was given the choice of providing subdistribution contact details to the recalling firm so the recalling firm could inform them of the recall, or the consignee can notify their downstream customers of the recall.

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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