FDA Device recall Z-1948-2019
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of o…
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of o… by Zimmer Biomet, citing there is a potential for weak seals of the sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1948-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-28 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Reason
There is a potential for weak seals of the sterile packaging.
Identifiers
| code_info | Lot Numbers: 187764 193497 193567 232280 232683 232684 232685 232686 233858 234049 235477 BFI0LJ8 BFI0M5B…Lot Numbers: 187764 193497 193567 232280 232683 232684 232685 232686 233858 234049 235477 BFI0LJ8 BFI0M5B BFI0MAV BFI0N16 BFI0NNN I0N17 I0N18 BFI0LJ8R BFI0MAVR BF10LJ8 BF10MAV BFIOLI8 I0NNN |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1948-2019%22
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