Reported Oct 30, 2019 · Terminated
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder…
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?
- Ergo 3.2mm
- K-wire - Product UsageThe devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use
- Lot codes and dates
- Catalog Number321-52-06, All Serial Numbers
- Amount recalled
- 158 devices
Where it was sold
Why it was recalled
Potential for the wire to fracture at the threads and remain in the glenoid.
This product could cause temporary or reversible health problems — stop using it.
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