Z-2362-2012 Class II Terminated
FDA device recall Z-2362-2012 was initiated by Exactech, Inc. on Jan 24, 2012 and is designated Class II. 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. The recall status is terminated (terminated Sep 26, 2012). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 19, 2012
- Initiation Date
- Jan 24, 2012
- Termination Date
- Sep 26, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm 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.
Distribution Pattern
Nationwide distribution: USA state of: Arkansas only
Code Information
Catalog Number: 101-05-30. Serial Numbers:2218601 and 2218603.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2362-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026