—#191658

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

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061808
Affected lot / code info: Model No. DCS2825126; Lot No. 11012187061566009

Why it was recalled

Product was labelled with the incorrect manufacturing and distribution dates.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: International distribution in the countries of Japan and the United Kingdom.

Timeline

Recall initiated: 2022-02-09
Terminated: 2024-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191658. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.