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.
Reported: July 10, 2019 Initiated: May 28, 2019 #Z-1948-2019
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 3022 total
- Distribution
- Worldwide Distribution - US Nationwide: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH OK, OR, PA, SC, TN, TX, UT, WA, WI, WV, and Puerto Rico. Products were distributed to the following foreign countries: Australia, Canada, Chile, Japan, Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 3022 total.
Why was this product recalled? ▼
There is a potential for weak seals of the sterile packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1948-2019.
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