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.
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 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…
- Manufacturer
- Exactech, Inc.
- 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
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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