FDA recall Z-1738-2019

Zimmer Biomet, Inc. · Class II · device

Product

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large

Reason for recall

Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

Distribution

CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS

Key facts

Status
Terminated
Initiation date
2019-04-18
Report date
2019-06-12
Termination date
2020-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1738-2019