Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
Reported: December 16, 2015 Initiated: October 20, 2015 #Z-0372-2016
Product Description
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 9 units
- Distribution
- International only Germany, Japan, Russia
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate. Recalled by Smith & Nephew, Inc.. Units affected: 9 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0372-2016.
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