FDAClass IIAugust 20, 2014

Ver2 DBL Offset Rasp Handle recall

VER2 DBL OFFSET RASP HANDLE, LT Nonsterile

Why was Ver2 DBL Offset Rasp Handle recalled?

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

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?

Item Number 82016761201 Lot Number 97009494, 97009561, 97009569

Product
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
Recalling firm
Zimmer, Inc.
Quantity
412 units
Distribution
Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
Recall date
August 20, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls