Recall Z-1557-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-1557-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-22

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-02-22, terminated 2015-05-21. It names one FDA 510(k) clearance: K011335. Product: Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011. Reason: The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-22
Terminated: 2015-05-21
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K011335 — SYNTHS ONE-THIRD TUBULAR DCL PLATESynthes (Usa)·cleared 2001-07-27

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

Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011

Reason for recall

The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.

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