Recall Z-2036-2017— Smith & Nephew, Inc.

Name: FDA recall Z-2036-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-22

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-03-22, terminated 2022-06-03. It names one FDA 510(k) clearance: K092015. Product: 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..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-22
Terminated: 2022-06-03
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K092015 — PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEMSmith & Nephew, Inc.·cleared 2009-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.