FDA-Device2019-11-13Class II
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
Zimmer Biomet, Inc.
Hazard
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Sold states
Distributed nationwide.
Affected count
5,459,583 total devices
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2020Don't want to check this manually?
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