The Recall Desk
HighFDA (Devices)·Z-2362-2012·Announced 2012-09-19

Exactech Recalls Novation Modular Drill Bits for Non-Sterile Condition

Exactech is recalling two Novation Modular Drill Bits after 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 surgical device used in a non-sterile condition, which presents a risk of harm (infection) even though specific injuries or illnesses are not explicitly reported in the source text.

Plain-English summary

Exactech, Inc. is recalling two units of the Novation Modular Drill Bit (Catalog Number 101-05-30). The specific units affected have serial numbers 2218601 and 2218603. These sterile, reusable surgical instruments are intended to assist surgeons in the implantation of Novation Hip system components for hemi and total hip arthroplasty.

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 stop using the affected drill bits immediately and contact Exactech, Inc. for instructions on how to return or dispose of the devices.

The recalled product

Product
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***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 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: 101-05-30. Serial Numbers:2218601 and 2218603.

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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