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DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02

FDA Recall #Z-0670-2023 — Class II — November 3, 2022

Recall #Z-0670-2023 Date: November 3, 2022 Classification: Class II Status: Ongoing

Product Description

DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02

Reason for Recall

XXX

Recalling Firm

DeRoyal Industries Inc — Powell, TN

Classification

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

Product Type

Devices

Product Quantity

N/A

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 56395179 exp 12/1/2023; Lot 56431133 exp 9/1/2023; Lot 57190554 exp 3/1/2024; Lot 5740754 exp 4/1/2024

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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