FDA recall Z-2849-2020

Product

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

Reason for recall

Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

Distribution

NV

Key facts

Status

Terminated

Initiation date

2020-07-20

Report date

2020-09-02

Termination date

2021-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2849-2020