CLASS II Device recall · Reported 19 Sep 2012 · FDA Enforcement Report
REF 101-45-40***Novation Modular Drill BIT Length: 40mm, Diameter recalled
Exactech is recalling REF 101-45-40***Novation Modular Drill BIT Length: 40mm, Diameter, distributed nationwide in the US. The recall was initiated on 24 Jan 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2366-2012
- FDA event ID
- 62140
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2012
- FDA classified
- 11 Sep 2012
- Reported
- 19 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 24 Jan 2012 | Recall initiated by company | |
| 11 Sep 2012 | Classified by FDA | +231 days |
| 19 Sep 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Where it was distributed
Nationwide distribution: USA state of: Arkansas only
Questions about this recall
Is REF 101-45-40***Novation Modular Drill BIT Length: 40mm, Diameter recalled?
Yes. Exactech recalled REF 101-45-40***Novation Modular Drill BIT Length: 40mm, Diameter on 24 Jan 2012. The recall is Class II and its status is Terminated. Recall number Z-2366-2012.
Why was it recalled?
Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Which lots are affected?
Catalog Number: 101-45-20. Serial Numbers:2139099 and 2139100.
Where was it sold?
Nationwide distribution: USA state of: Arkansas only
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |