Device product
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.
Z-2777-2020
Product summary
- Event
- Event 85946
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2777-2020
Official wording
Reason: The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
Code information: Product Number: 71173400, Lot Number: 16GM20026
Distribution pattern: U.S Nationwide including in the states of IN and TN.
Derived failure modes
-
Unknown
The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.