Reported Jul 12, 2017 · Terminated
Logic Fit Tibial Tamp Head
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?
- Logic Fit Tibial Tamp Head
- Lot codes and dates
Catalog #: 213-75-01 Lot #'s: 37166-00244944-00444944-00544944-00648073-01048073-01148073-01249036-01751180-00451180-00551180-00651180-00851754-03151754-03251754-03351754-03459743-00161872-001and 61872-002
- Amount recalled
- 573
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
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
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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