FDA recall record

Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH recall — FDA Z-2036-2017

This lot of left plates were laser etched and packaged as right plates.

Class IIclassification
Z-2036-2017official record ID
May 17, 2017report date

Recall record at a glance

Official recordZ-2036-2017
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmSmith & Nephew, Inc.
Report dateMay 17, 2017
Recall initiation dateMar 22, 2017
Quantity12 units
LocationMemphis, TN, United States

Official product description

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

Why the product was recalled

This lot of left plates were laser etched and packaged as right plates.

Distribution information

Internationally to the country of : India

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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