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U.S. Department of Health and Human Services

Class 2 Device Recall DARCO " LOCKING BONE PLATE SYSTEM

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  Class 2 Device Recall DARCO " LOCKING BONE PLATE SYSTEM see related information
Date Initiated by Firm February 09, 2022
Create Date February 25, 2022
Recall Status1 Open3, Classified
Recall Number Z-0679-2022
Recall Event ID 89461
510(K)Number K061808  
Product Classification Plate, fixation, bone - Product Code HRS
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
Code Information Model No. DCS2825126; Lot No. 11012187061566009
Recalling Firm/
Manufacturer
Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Meghan Wells
901-201-9198
Manufacturer Reason
for Recall
Product was labelled with the incorrect manufacturing and distribution dates.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 12 units
Distribution International distribution in the countries of Japan and the United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = DARCO INTERNATIONAL, INC.
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