Device product
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***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.
Z-2365-2012
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 62140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2365-2012
Official wording
Reason: 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.
Code information: Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028.
Distribution pattern: Nationwide distribution: USA state of: Arkansas only
Derived failure modes
-
Unknown
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.