—#141840

Product

Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083032
Affected lot / code info: Batch # 14KT47574

Why it was recalled

The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.

Root cause (FDA determination)

Employee error

Action the firm took

Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.

Recalling firm

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

Distribution

Distribution pattern: International only Germany, Japan, Russia

Timeline

Recall initiated: 2015-10-20
Posted by FDA: 2015-12-04
Terminated: 2016-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.