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
FDA Recall Z-0373-2016 · Posted 2015-12-04
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2015-10-20
Date Terminated2016-09-21
Product Quantity9 units
Reason for Recall
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.
Firm Action
Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.
Root Cause
Employee error
Distribution Pattern
International only Germany, Japan, Russia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.