Recall Z-2548-2018 ยท HTO Reamer
Cayenne Medical Inc.
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
| Date | Apr 28, 2010 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | Customers were contacted via email on approximately 10/10/2013 and were instructed to return any affected products on hand. |
| Quantity | 1,444 units total |
| Distribution | Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.