FDA recall Z-2422-2018

Product

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.

Reason for recall

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

Distribution

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2013-07-11

Report date

2018-07-18

Termination date

2018-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Scottsdale, AZ, United States

Primary source

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