Z-1740-2019 Class II Terminated
FDA device recall Z-1740-2019 was initiated by Zimmer Biomet, Inc. on April 18, 2019 and is designated Class II. Reason for recall: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. The recall status is terminated (terminated September 10, 2020). Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- April 18, 2019
- Termination Date
- September 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
Reason for Recall
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Distribution Pattern
CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
Code Information
Lot Numbers: ZB160601 ZB170201 ZB170201 ZB170601