Skip to content
Recall Observatory FDA recall evidence

Device product

Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate

Z-0373-2016

October 20, 2015

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 72655
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-0373-2016

Official wording

Reason: 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.

Code information: Batch # 14KT47575

Distribution pattern: International only Germany, Japan, Russia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.