Z-0306-2020 Class II Terminated
FDA device recall Z-0306-2020 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
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
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-0306-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026