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

FDA Recall #Z-0393-2022 — Class II — December 3, 2021

Recall #Z-0393-2022 Date: December 3, 2021 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

The incorrect product is contained in the packaging.

Recalling Firm

Wright Medical Technology Inc — Arlington, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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.

Code Information

Lot #1643355

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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