Recall Z-0401-2022 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
| Date | Dec 3, 2021 |
| Status | Open, Classified |
| Reason | Incorrect product is contained in the packaging. |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141417 | CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW Wrightmedicaltechnologyinc, Jul 9, 2014 |