Recall Z-2777-2020— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-06-29, terminated 2022-02-18. FDA's recall record names no specific 510(k) clearance for this event. 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: The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-29
- Terminated
- 2022-02-18
- Firm location
- Memphis, TN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.