CLASS II Device recall · Reported 16 Dec 2015 · FDA Enforcement Report
Peri-loc Volar Distal Radius Plate Standard 3 Hole Short recalled
Smith & Nephew is recalling Smith & Nephew Peri-loc Volar Distal Radius Plate Standard 3 Hole Short, Right -, Sterile, distributed nationwide in the US. The recall was initiated on 20 Oct 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0373-2016
- FDA event ID
- 72655
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2015
- FDA classified
- 4 Dec 2015
- Reported
- 16 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2015 | Recall initiated by company | |
| 4 Dec 2015 | Classified by FDA | +45 days |
| 16 Dec 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
International only Germany, Japan, Russia
Questions about this recall
Is Peri-loc Volar Distal Radius Plate Standard 3 Hole Short, Right -, Sterile R recalled?
Yes. Smith & Nephew recalled Peri-loc Volar Distal Radius Plate Standard 3 Hole Short, Right -, Sterile R on 20 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0373-2016.
Why was it 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.
Which lots are affected?
Batch # 14KT47575
Where was it sold?
International only Germany, Japan, Russia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Smith & Nephew
All 258| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew | Smith & Nephew | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Biosure HA Screw Threaded metallic bone fixation fastener recalled | Smith & Nephew | Labeling Errors | Nationwide |
| Device | CLASS II | Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew | Smith & Nephew | Other | Nationwide |
| Device | CLASS II | Bioraptor Suture Anchors recalled by Smith & Nephew | Smith & Nephew | Sterility | Nationwide |
| Device | CLASS II | Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew | Smith & Nephew | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |