Z-0329-2020 Class II Terminated
FDA device recall Z-0329-2020 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
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700
Reason for Recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution Pattern
Distributed nationwide.
Code Information
All products manufactured prior to January 2014.