CLASS II ONGOING Device recall · Reported 29 Dec 2021 · FDA Enforcement Report

Charlotte MTP Hex Screw recalled by Wright Medical Technology

Wright Medical Technology is recalling Wright Medical Technology Inc. Charlotte MTP Hex Screw, distributed nationwide in the US. The recall was initiated on 3 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.

Quantity recalled22 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0401-2022
FDA event ID: 89086
Recalling firm: Wright Medical Technology, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2021
FDA classified: 20 Dec 2021
Reported: 29 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

3 Dec 2021	Recall initiated by company
20 Dec 2021	Classified by FDA	+17 days
29 Dec 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect product is contained in the packaging.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Arizona Iowa South Carolina

Questions about this recall

Is Charlotte MTP Hex Screw recalled?

Yes. Wright Medical Technology recalled Charlotte MTP Hex Screw on 3 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0401-2022.

Why was it recalled?

Incorrect product is contained in the packaging.

Which lots are affected?

Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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