Z-0298-2020 Class II Terminated
FDA device recall Z-0298-2020 was initiated by Zimmer Biomet, Inc. on October 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
- November 13, 2019
- Initiation Date
- October 10, 2019
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,459,583 total devices
Product Description
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100
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.