Agency classClass IIOur severity:High FDA (Devices)·Z-2365-2012·Announced 2012-09-19

Exactech Recalls Novation Modular Drill Bits Due to Sterility Issues

Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk surgical instrument used in a non-sterile condition, which presents a significant risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Exactech, Inc. is recalling two units of the Novation Modular Drill Bit (Catalog Number 101-45-30). The specific serial numbers involved in this recall are 2139027 and 2139028. These medical devices are reusable, surgically invasive instruments intended for transient use to assist surgeons in the implantation of Novation Hip system components.

The recall was initiated after the devices were reported to have been used by an end user while in a non-sterile condition. The affected units were distributed only to the state of Arkansas.

Healthcare facilities and end users should check their inventory for the specific serial numbers listed above. If these devices are found, they should be removed from service and returned to Exactech, Inc. according to the company's instructions.

The recalled product

Product: REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Manufacturer: Exactech, Inc.
Category: Medical Device — Surgical Instrument
Hazard: infection
sterility-failure
Affected units: 2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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