Zimmer Biomet, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Zimmer Biomet, Inc. is recalling K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instrumen due to There is a potential for weak seals of the sterile packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for weak seals of the sterile packaging.
Recommended Action
Per FDA guidance
Urgent Medical Device Recall notification letters dated 5/28/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026