Reported Jul 12, 2017 · Terminated
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
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?
- EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
- Lot codes and dates
- All Lots
- Amount recalled
- 2,069
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
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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