Smith & Nephew Peri-loc Volar Distal Radius Plate recall
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
Why was Smith & Nephew Peri-loc Volar Distal Radius Plate 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # 14KT47575
- 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
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 9 units
- Distribution
- International only Germany, Japan, Russia
- Recall date
- December 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)