RecallRadar

FDA Device recall Z-1011-2018

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

On 2018-03-21 the FDA classified a Class II recall of Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty by Zimmer Biomet, citing the affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1011-2018
ClassificationClass II
Statusterminated
Initiated2017-10-03
Published2018-03-21
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionFL, MD, MI, MO, WI

Product

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Reason

The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Identifiers

code_infoItem #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1011-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.