Z-0373-2016Class II

Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only...

Name: Z-0373-2016 Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only...
Creator: Smith & Nephew, Inc.
Published: 2015-10-20
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2015-10-20 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of 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 on 2015-10-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0373-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-20
Posted: 2015-12-04
Terminated: 2016-09-21
Recalling firm: Smith & Nephew, Inc.
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
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.
Quantity in commerce: 9 units
Distribution: International only Germany, Japan, Russia
Product codes and lots: Batch # 14KT47575

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0373-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0372-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0373-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04

Product code HRS

K083032Class IIPeri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. / cleared 2009-01-07

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)