—#182236

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Product Number: 71173400, Lot Number: 16GM20026

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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)

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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

Timeline

Recall initiated: 2020-06-29
Terminated: 2022-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182236. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.