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.
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 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…
- Manufacturer
- Exactech, Inc.
- 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
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.
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