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Recall Observatory FDA recall evidence

Device product

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.

Z-2362-2012

January 24, 2012

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 62140
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2362-2012

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: 101-05-30. Serial Numbers:2218601 and 2218603.

Distribution pattern: Nationwide distribution: USA state of: Arkansas only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.