FDA-Device2018-07-18Class II

AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.

Cayenne Medical Inc.
Hazard

Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.

Sold states
US nationwide distribution.
Affected count
976 units
Manufactured in
16597 N 92nd St Ste 101, Scottsdale, AZ, United States
Products
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2422-2018

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