FDAClass IIJuly 10, 2019

K-Wire Trochar Tip recall

K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic…

Why was K-Wire Trochar Tip 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: 187764 193497 193567 232280 232683 232684 232685 232686 233858 234049 235477 BFI0LJ8 BFI0M5B BFI0MAV BFI0N16 BFI0NNN I0N17 I0N18 BFI0LJ8R BFI0MAVR BF10LJ8 BF10MAV BFIOLI8 I0NNN

Product
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic…
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