Reported Sep 18, 2019 · Terminated
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system…
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?
- Threaded
- Offset Cup Impactor - Product UsageTo assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use
- Lot codes and dates
- Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001
- Amount recalled
- 22 devices
Where it was sold
Why it was recalled
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
This product could cause temporary or reversible health problems — stop using it.
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