NexGen Precoat Stemmed Tibial Plate Size 5
FDA Recall #Z-2092-2023 — Class II — May 19, 2023
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.