Z-0679-2022Class II

The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible...

Name: Z-0679-2022 The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible...
Creator: Wright Medical Technology, Inc.
Published: 2022-02-09
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-02-09 / Terminated / root cause: packaging

FDA source

Wright Medical Technology, Inc. began a recall of 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... on 2022-02-09. FDA classified it as Class II and gives the reason as "Product was labelled with the incorrect manufacturing and distribution dates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0679-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-09
Posted: 2022-02-25
Terminated: 2024-01-25
Recalling firm: Wright Medical Technology Inc
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
Product code: HRS Plate, Fixation, Bone
Reason for recall: Product was labelled with the incorrect manufacturing and distribution dates.
Root cause tag: packaging
FDA 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 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 [email protected] 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.
Product codes and lots: Model No. DCS2825126; Lot No. 11012187061566009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0679-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0679-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-25

Product code HRS

K061808Class IIDarco Locking Bone Plate SystemDarco International, Inc. / cleared 2006-08-17

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)