Exactech Recalls Novation Modular Drill Bits for Sterility Issues
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 risk-of-harm product (surgical instrument) where the hazard is the use of a non-sterile device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Exactech, Inc. is recalling two units of the Novation Modular Drill Bit (Catalog Number 101-45-20). The specific serial numbers involved in this recall are 2138948 and 2138950. These devices are reusable, surgically invasive instruments intended for transient use to assist surgeons in the implantation of Novation Hip system components.
The recall was initiated after reports indicated that the devices were used by end users 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. Exactech is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm 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:2138948 and 2138950.
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Exactech, Inc.
See all →- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- ModeratePilot tip converters recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamers recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- LowExactech Recalls Novation Hip Stems Due to Incorrect GTIN Labeling
FDA (Devices) · 2016-07-13
- ModerateExactech Recalls Novation Femoral Stems Due to Premature Packaging
FDA (Devices) · 2016-06-08
- ModerateExactech Recalls One Novation Femoral Stem for Premature Packaging
FDA (Devices) · 2016-06-08
- ModerateExactech Recalls One Novation Femoral Stem Device for Premature Packaging
FDA (Devices) · 2016-06-08
- ModerateExactech Recalls Threaded Offset Cup Impactor Due to Gritty Mechanism
FDA (Devices) · 2019-09-18
- LowExactech Recalls Hip Replacement Stems Due to Incorrect GTIN Labeling
FDA (Devices) · 2016-07-13