Device Recall Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instr 의 리콜

510 K exempt. All lots I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H1427HFOO "

Orthopedic Devices

1

No

USA (nationwide distribution)

Brand Name: Custom Straight Accolade¿¿ Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Specialty Straight Command¿¿ Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Custom Straight Accolade¿¿ || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Custom Accolade¿¿ Broach Handle || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Custom Accolade¿¿ Broach Handle || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Specialty Locking Accolade¿¿ Straight Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Specialty Woodpecker Adapted Accolade¿¿ Broach || Handle || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430 || The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures. The rasps have a geometry similar to the final size and shape of the implant. The straight design allows the rasp handle to be used in standard or minimally invasive approaches because it minimizes the contact with adjacent soft tissue. The Handle is impacted with a slotted mallet on the top and on the bottom portions of the striking plate, to achieve rasp insertion and extraction respectively. The handles share the same geometry in the region that is of interest in this matter.