—#154604

Product

PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K092015
Affected lot / code info: Lot 16DM15958

Why it was recalled

This lot of left plates were laser etched and packaged as right plates.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Smith & Nephew initiated their recall by email on March 22, 2017. Consignees are being requested to return all affected product in their possession. Distributors were instructed to notify their customers and ensure that the recall instructions were followed. For further questions, please call : 1(800) 821-5700.

Recalling firm

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

Distribution

Distribution pattern: Internationally to the country of : India

Timeline

Recall initiated: 2017-03-22
Posted by FDA: 2017-04-14
Terminated: 2022-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.