Recall Z-0393-2022 ยท HRS Plate, Fixation, Bone
Wright Medical Technology Inc
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
| Date | Dec 3, 2021 |
| Status | Open, Classified |
| Reason | The 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 labeled as the CLAW II 4 Hole Plates and the packages labeled as the DARCO Locking Screws were switched, resulting in the packages containing the incorrect product. The letter also provided the potential risks, the actions needed to be taken, and provided example labels of affected products. 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 |
| Quantity | 250 units |
| Distribution | Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061808 | DARCO LOCKING BONE PLATE SYSTEM Darco International, Inc., Aug 17, 2006 |