FDA Recall Open, Classified

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

Recall: Z-0401-2022 · Initiated December 3, 2021

Recall

Recall Number
Z-0401-2022
Event Number
89086
Firm
Wright Medical Technology, Inc.
FEI Number
3010667733
Product Code
HRS
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
December 3, 2021
Address
1023 Cherry Rd, Memphis, TN, 38117-5423

Description

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

Reason

Incorrect product is contained in the packaging.

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.

Distribution

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

Quantity

22 units