REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm — Class II medical device recall Z-2363-2012
Terminated recall by Exactech, Inc., reported 2012-09-19, distributed nationwide. Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reporte
| Recall number | Z-2363-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2012-01-24 |
| Classified | 2012-09-11 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2012-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | sterility |
| Serial numbers | 2193123, 2193124 |
| Model numbers | 101-05-40 |
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 for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.