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 high-risk, surgically invasive medical device used in a non-sterile condition, which presents a significant risk of harm (infection), but the source text does not report any confirmed illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Exactech, Inc. is recalling two units of the Novation Modular Drill Bit (Catalog Number 101-05-40). The specific units involved have serial numbers 2193123 and 2193124. These devices are reusable, surgically invasive instruments intended for transient use 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 source text does not specify the date of the incident, the specific hospital or facility where the use occurred, or whether any patients experienced adverse health outcomes as a result.
The affected units were distributed nationwide but are specifically identified as being in the state of Arkansas. Consumers and healthcare facilities should check their inventory for these specific serial numbers and stop using the devices if found.
The recalled product
- Product
- REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***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.
- 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: 101-05-40. Serial Numbers:2193123 and 2193124.
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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