FDA recall Z-0327-2020

Zimmer Biomet, Inc. · Class II · device

Product

CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Distribution

Distributed nationwide.

Key facts

Status
Terminated
Initiation date
2019-10-10
Report date
2019-11-13
Termination date
2020-05-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0327-2020