The Recall Desk
HighFDA (Devices)·Z-2364-2012·Announced 2012-09-19

Exactech Recalls Novation Modular Drill Bits for Sterility Issues

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

What this means for you

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 risk-of-harm product (surgical instrument) where the hazard is the use of a non-sterile device, 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 101-45-20). The specific serial numbers involved in this recall are 2138948 and 2138950. These 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 reports indicated that the devices were used by end users while in a non-sterile condition. The affected units were distributed only to the state of Arkansas.

Healthcare facilities and end users should stop using the affected drill bits immediately. Exactech is the recalling firm responsible for managing this safety action.

The recalled product

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 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
Manufacturer
Exactech, Inc.
Category
Medical Device — Surgical Instrument
Hazard
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: 101-45-20. Serial Numbers:2138948 and 2138950.

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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