Zimmer Biomet, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1946-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

Product Classification:

Class II

Date Initiated: May 28, 2019

Date Posted: July 10, 2019

Recall Number: Z-1946-2019

Event ID: 83024

Reason for Recall:

There is a potential for weak seals of the sterile packaging.

Status: Terminated

Product Quantity: 3022 total

Code Information:

Lot Numbers: 235471 235472 235473 235474 235475 187762 193492 193493 193494 193495 193496 193565 BF10LBJ BFI0LBJ BFI0M9E BFI0N10 BFI0N11 BFI0P39 I0N0X I0N0XR I0N0Y I0N10 I0N11 I0N5B I0P39 225207 BFIOLBJ I0N5P

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.

Voluntary or Mandated:

Voluntary: Firm initiated