Reported Sep 19, 2012 · Terminated
REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- REF 101-45-40***NOVATION
- MODULAR DRILL BIT LENGTH40mm, 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
- Lot codes and dates
- Catalog Number101-45-20
- Serial Numbers2139099 and 2139100
- Amount recalled
- 2
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- AR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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