Recall Z-1948-2019— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-05-28, terminated 2021-11-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-28
- Terminated
- 2021-11-19
- Firm location
- Warsaw, IN, United States
Product description
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 for recall
There is a potential for weak seals of the sterile packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.