NexGen Precoat Stemmed Tibial Plate Size 5

FDA Recall #Z-2092-2023 — Class II — May 19, 2023

Recall #Z-2092-2023 Date: May 19, 2023 Classification: Class II Status: Ongoing

Product Description

NexGen Precoat Stemmed Tibial Plate Size 5

Reason for Recall

Device outer packaging was incorrectly labeled.

Recalling Firm

Zimmer, Inc. — Warsaw, IN

Classification

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

Product Type

Devices

Product Quantity

N/A

Distribution

International distribution in the country of India.

Code Information

Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.

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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