FDAClass IIJuly 10, 2019

DVR Crosslock ePAK Depth Gauge recall

DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of…

Why was DVR Crosslock ePAK Depth Gauge 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: 226646 230493 231877 232682 235476 BFI0LBKR 187763 193566 BF10LBK BFA012345 BFI0LBK BFI0M4H BFI0M9F BFI0N13 BFI0N14 BFION15 I0N12 I0N12R I0N13 BF10M9F BFIOLBK

Product
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 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