The Recall Desk
HighFDA (Devices)·Z-2366-2012·Announced 2012-09-19

Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

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 sterile medical device used in a non-sterile condition, which presents a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Exactech, Inc. is recalling two units of the Novation Modular Drill Bit (REF 101-45-40). The recall was initiated after reports indicated that the devices were used by end users while in a non-sterile condition.

The affected products are sterile, reusable surgical instruments intended to assist surgeons in the implantation of Novation Hip system components for hemi and total hip arthroplasty. The specific units involved have Catalog Number 101-45-20 and Serial Numbers 2139099 and 2139100.

These devices were distributed nationwide, specifically to the state of Arkansas. Healthcare facilities and end users should verify their inventory against the provided serial numbers and contact Exactech for further instructions regarding the return or replacement of these items.

The recalled product

Product
REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm 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:2139099 and 2139100.

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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