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GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13

FDA Recall #Z-0567-2023 — Class II — November 3, 2022

Recall #Z-0567-2023 Date: November 3, 2022 Classification: Class II Status: Ongoing

Product Description

GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13

Reason for Recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Recalling Firm

DeRoyal Industries Inc — Powell, TN

Classification

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

Product Type

Devices

Product Quantity

79 units

Distribution

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Code Information

Lot Numbers: Lot 56184443 exp 5/1/2023; Lot 56618408 exp 1/1/2023; Lot 57589531 exp 12/1/2023

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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