Z-0393-2022Class II

Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm

Name: Z-0393-2022 Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm
Creator: Wright Medical Technology Inc
Published: 2021-12-03
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2021-12-03 / Open, Classified / root cause: packaging

FDA source

Wright Medical Technology Inc began a recall of Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm on 2021-12-03. FDA classified it as Class II and gives the reason as "The incorrect product is contained in the packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0393-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-03
Posted: 2021-12-17
Recalling firm: Wright Medical Technology Inc
Product: Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The incorrect product is contained in the packaging.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The recalling firm issued a recall letter dated 03 Dec 2021 on 12/3/2021 via Fed Ex Priority Overnight. The letter explained the packages labeled as the CLAW II 4 Hole Plates and the packages labeled as the DARCO Locking Screws were switched, resulting in the packages containing the incorrect product. The letter also provided the potential risks, the actions needed to be taken, and provided example labels of affected products. The consignee is to immediately check their inventory to locate the packaged product and remove them from their point of use. The enclosed business reply form was to be returned via email to confirm receipt of the letter and document product segregation. After the firm receives the reply form, the consignee will be contacted to arrange for return and replacement. The consignee was given the choice of providing subdistribution contact details to the recalling firm so the recalling firm could inform them of the recall, or the consignee can notify their downstream customers of the recall.
Quantity in commerce: 250 units
Distribution: Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
Product codes and lots: Lot #1643355

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0393-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0392-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-17
Z-0393-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-17

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)