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Recall Observatory FDA recall evidence

Device product

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.

Z-1946-2019

May 28, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83024
Status
Terminated
Classification
Class II
Quantity
3022 total
Official record key
device-enforcement:Z-1946-2019

Official wording

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

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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    weak seals of the sterile packaging