Skip to content
Recall Observatory FDA recall evidence

Device product

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small

Z-1736-2019

April 18, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 82818
Status
Terminated
Classification
Class II
Quantity
41 units
Official record key
device-enforcement:Z-1736-2019

Official wording

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

Code information: Lot Numbers: ZB160201 ZB160401 ZB161101 ZB170401 ZB170601 ZB170801 ZB170901

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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