Z-2036-2017Class II

PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY...

Name: Z-2036-2017 PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY...
Creator: Smith & Nephew, Inc.
Published: 2017-03-22
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-03-22 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc... on 2017-03-22. FDA classified it as Class II and gives the reason as "This lot of left plates were laser etched and packaged as right plates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2036-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-22
Posted: 2017-04-14
Terminated: 2022-06-03
Recalling firm: Smith & Nephew, Inc.
Product: PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
Product code: HRS Plate, Fixation, Bone
Reason for recall: This lot of left plates were laser etched and packaged as right plates.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: Smith & Nephew initiated their recall by email on March 22, 2017. Consignees are being requested to return all affected product in their possession. Distributors were instructed to notify their customers and ensure that the recall instructions were followed. For further questions, please call : 1(800) 821-5700.
Quantity in commerce: 12 units
Distribution: Internationally to the country of : India
Product codes and lots: Lot 16DM15958

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2036-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2036-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05

Product code HRS

K092015Class IIPeri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. / cleared 2009-07-30

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)