Z-0401-2022Class II

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

Name: Z-0401-2022 Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the...
Creator: Wright Medical Technology, Inc.
Published: 2021-12-03
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2021-12-03 / Open, Classified / root cause: packaging

FDA source

Wright Medical Technology, Inc. began a recall of Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System on 2021-12-03. FDA classified it as Class II and gives the reason as "Incorrect product is contained in the packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0401-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-03
Posted: 2021-12-20
Recalling firm: Wright Medical Technology Inc
Product: Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Incorrect product is contained in the packaging.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 22 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, and United Kingdom.
Product codes and lots: Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0401-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0401-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-20

Product code HRS

K141417Class IICharlotte (Tm) Mtp Bone Fusion Plate System Hex ScrewWrightmedicaltechnologyinc / cleared 2014-07-09

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)