FDA recall Z-2777-2020

Smith & Nephew, Inc. · Class II · 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.

Reason for recall

The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.

Distribution

U.S Nationwide including in the states of IN and TN.

Key facts

Status
Terminated
Initiation date
2020-06-29
Report date
2020-08-19
Termination date
2022-02-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2777-2020