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.
This recall has been terminated (originally issued June 29, 2020).
- Company
- Smith & Nephew Inc
- Recall Initiated
- June 29, 2020
- Terminated
- February 18, 2022
- Recall Number
- Z-2777-2020
- Quantity
- 3 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Product Number: 71173400, Lot Number: 16GM20026
Root Cause
Process design
Action Taken
The firm sent a letter to customers dated 06/29/2020 and titled "Urgent Medical Device Recall Notice". The letter informs customers of a field action to voluntarily remove a single lot of PeriLoc Targeters due to a manufacturing error. Customers should inspect their inventory and locate any devices from the listed product and batch numbers enclosed with the Recall Notice, and quarantine them immediately. Sales reps or distributors, should notify customers of the field action and ensure that the required actions are complete. Customers should completed a form identifying if they have product to return or no product to return. Customers returning product should list batches and quantities that are being returned. Completed forms should be signed and send to FieldActions@smith-nephew.com. The firm's contact information: FieldActions@smith-nephew.com. T: + 1 901 396 2121 T: 1 800 821 5700 (USA toll free)