Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Zimmer, Inc. NexGen Precoat Stemmed Tibial Plate (Size 5) [Model No.: 00598004701; UDI No./Lot No.: (01)00889024217607(17)321228(10) J7418537 / J7418537 and (01)00889024217607(17)321228(10)J7418542 / J7418542]. [HKMD No.: 090359].
According to the FDA, device outer packaging was incorrectly labelled.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92531
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Jul 2023