Z-1947-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- May 28, 2019
- Termination Date
- November 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3022 total
Product Description
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 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.
Distribution Pattern
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.
Code Information
Lot Numbers: 226646 230493 231877 232682 235476 BFI0LBKR 187763 193566 BF10LBK BFA012345 BFI0LBK BFI0M4H BFI0M9F BFI0N13 BFI0N14 BFION15 I0N12 I0N12R I0N13 BF10M9F BFIOLBK