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, lengths, number of plate holes and through different grades and bridge widths Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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, lengths, number of plate holes and through different grades and bridge widths
Brand
Wright Medical Technology, Inc.
Lot Codes / Batch Numbers
Model No. DCS2825126, Lot No. 11012187061566009
Products Sold
Model No. DCS2825126; Lot No. 11012187061566009
Wright Medical Technology, Inc. is recalling The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatibl due to Product was labelled with the incorrect manufacturing and distribution dates.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was labelled with the incorrect manufacturing and distribution dates.
Recommended Action
Per FDA guidance
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 expiration dates on this product, product still in stock may not be sterile and/or the sterile barrier packaging containing these devices may no longer meet sterility requirements. The recalling firm asks that customers inform individuals within the organization who need to know of this recall, immediately check stock and operating rooms for recalled devices, quarantine any affected devices, and complete the required response form within 7 calendar days of receipt of the recall notice. Completed forms are to be sent via email to memphis.fieldaction@stryker.com by 02/15/2022. Additional action required of customers is that they inform Stryker of any devices further distributed and any adverse events reported to your organization involving recalled product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026