FDA-Device2019-11-13Class II
PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 00234802112 00234802204 00234802206 00234802208 00234802212 00234802508 00234802510 00234802608
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
PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 00234802112 00234802204 00234802206 00234802208 00234802212 00234802508 00234802510 00234802608
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0315-2020Don't want to check this manually?
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