Reported Aug 1, 2018 · Terminated
AperFix Femoral Implant Coring Removal Drill, labeled as the following
Cayenne Medical 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: Cayenne Medical Inc. · 16597 N 92nd St Ste 101 · Scottsdale, AZ · 85260-1847
Is this the product you have?
AperFix Femoral Implant Coring Removal Drill, labeled as the following
6 of 6 products
| Model / number | Product as published |
|---|---|
CM-7109 | Femoral Removal Coring Reamer 9mm |
CM-7110 | Femoral Removal Coring Reamer 10mm |
CM-7111 | Femoral Removal Coring Reamer 11mm |
CM-7129 | Femoral Removal Coring Reamer 9 mm - Long |
CM-7130 | Femoral Removal Coring Reamer 10 mm - Long |
CM-7131 | Femoral Removal Coring Reamer 11 mm - Long, ; Orthopedic surgical instrument. |
- Amount recalled
- 1,444 units total
Where it was sold
- Nationwide
Why it was recalled
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
This product could cause temporary or reversible health problems — stop using it.
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