Recall record at a glance
| Official record | Z-2548-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cayenne Medical Inc. |
| Report date | Aug 1, 2018 |
| Recall initiation date | Apr 28, 2010 |
| Quantity | 1,444 units total |
| Location | Scottsdale, AZ, United States |
Official product description
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
Why the product 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.
Distribution information
Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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