FDAClass IISeptember 19, 2012

REF 101-45-20***novation Modular Drill BIT Length: 20mm recall: Sterility Concern

REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL…

Why was REF 101-45-20***novation Modular Drill BIT Length: 20mm recalled?

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

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?

Catalog Number: 101-45-20. Serial Numbers:2138948 and 2138950.

Product
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL…
Recalling firm
Exactech, Inc.
Quantity
2
Distribution
Nationwide distribution: USA state of: Arkansas only
Recall date
September 19, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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