CHARLOTTE recallZ-0401-2022 · Wright Medical Technology, Inc. · initiated Dec 3, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wright Medical Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect product is contained in the packaging.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0401-2022
- Status
- Open, Classified
- Initiated by the company
- Dec 3, 2021
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 22 units
- Product code
- HRS
- FDA submissions
- K141417
- 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 description
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Code information (models, lots, serial numbers)
Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CHARLOTTE 41122718Wright Medical Technology, Inc. · PLATE, FIXATION, BONE1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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