Recall Z-0679-2022 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, l
| Date | Feb 9, 2022 |
| Status | Terminated |
| Reason | Product was labelled with the incorrect manufacturing and distribution dates. |
| Root cause | Packaging process control |
| Action | An email communication titled "URGENT: FIELD SAFETY NOTICE" was distributed by email to customers on 02/09/2022 that informs customers of a recall of DARCO Non-Locking Screw OD:2.7 mm L: 26mm, Lot No. 11012187061566009. These products were distributed from December 2015 to January 2018. The firm identified the reason for recall as the product being incorrectly labeled with a manufacturing date of 2015-12-16 and an expiration date of 2023-12-14, when the actual manufacturing date is 2010-11-01 and actual expiration date is 2018-11-01. Due to the incorrect labeling of manufacturing and expiratio |
| Quantity | 12 units |
| Distribution | International distribution in the countries of Japan and the 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 |