FDAClass IIJuly 10, 2019

DVR Crosslock ePAK Screw Driver recall

DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of…

Why was DVR Crosslock ePAK Screw Driver recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of…
Recalling firm
Zimmer Biomet, Inc.
Quantity
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.
Recall date
July 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls