Z-0309-2020 Class II Terminated
FDA device recall Z-0309-2020 was initiated by Zimmer Biomet, Inc. on Oct 10, 2019 and is designated Class II. Reason for recall: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). The recall status is terminated (terminated May 19, 2020). Affected quantity: 5,459,583 total devices.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 13, 2019
- Initiation Date
- Oct 10, 2019
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,459,583 total devices
Product Description
Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 47235700518 47235700604 47235700606 47235700608 47235700610 47235700612 47235700614 47235700618 47235700706 47235700708 47235700710 47235700714 47235700808 47235700810 47235700814 47235700906 47235700908 47235700914 47235700918 47235701006 47235701008 47235701010
Reason for Recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution Pattern
Distributed nationwide.
Code Information
All product manufactured prior to January 2014.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0309-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026