FDA-Device2015-12-16Class II

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

Smith & Nephew, Inc.
Hazard

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.

Sold states
International only Germany, Japan, Russia
Affected count
9 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2016

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