FDA Enforcement Class II Terminated

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

Recall: Z-2036-2017 · Reported May 17, 2017

Enforcement

Recall Number
Z-2036-2017
Event ID
76934
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Smith & Nephew, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
May 17, 2017
Initiation Date
March 22, 2017
Classification Date
May 5, 2017
Termination Date
June 3, 2022
Address
1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

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

Reason

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

Code Info

Lot 16DM15958

Distribution

Internationally to the country of : India

Quantity

12 units