Recall Z-1386-2016— Synthes (USA) Products LLC

Name: FDA recall Z-1386-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-08

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-12-08, terminated 2016-08-26. It names 2 FDA 510(k) clearances: K131792, K113071. Product: SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.. Reason: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-12-08
Terminated: 2016-08-26
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAYSynthes, Inc.·cleared 2013-12-16
K113071 — SYNTHECEL DURA REPLACEMENT DEVICESSynthes·cleared 2012-01-09

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

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

Reason for recall

It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.

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