FDAClass IIFebruary 14, 2018

Drill BIT Mini Quick Connect 1.0mm recall

DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

Why was Drill BIT Mini Quick Connect 1.0mm recalled?

A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture

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?

231220200 Item Number with the following Lot numbers 45785,46151, 47467, 48461, 48809, 100016 & 102325 231220202 Item Number with the following Lot Numbers: 45790, 48477, 48811, 100017, 101028 & 102338

Product
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Recalling firm
Zimmer Biomet, Inc.
Quantity
1,524 units
Distribution
AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland
Recall date
February 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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