Recalls / —

—#190462

Product

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

FDA product code

HRS — Plate, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K061808

Affected lot / code info

Lot #1643355

Why it was recalled

The incorrect product is contained in the packaging.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Wright Medical Technology Inc

Address

11576 Memphis Arlington Rd, Arlington, Tennessee 38002-9497

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2021-12-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #190462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.