Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD… recallZ-0373-2016 · Smith & Nephew, Inc. · initiated Oct 20, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.
Recall details
- Recall number
- Z-0373-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 20, 2015
- Posted by the FDA
- Dec 4, 2015
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 9 units
- Product code
- HRS
- FDA submissions
- K083032
- Distribution
- International only Germany, Japan, Russia
Product description
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
Code information (models, lots, serial numbers)
Batch # 14KT47575
Other devices under the same FDA submission
14 devices cleared under K083032 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Peri-Loc 71860013Smith & Nephew, Inc. · PLATE, FIXATION, BONE2 reports
- Peri-Loc 71860110Smith & Nephew, Inc. · PLATE, FIXATION, BONE2 reports
- Peri-Loc 71867064Smith & Nephew, Inc. · PLATE, FIXATION, BONE2 reports
- Peri-Loc 71861013Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71861303Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71860006Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71860106Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71860108Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71860113Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71865036Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71867046Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71867056Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 72655).
- Z-0372-2016 · TerminatedSmith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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