Z-0300-2020 Class II Terminated
FDA device recall Z-0300-2020 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
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
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-0300-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026