Z-1383-2016Class II

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing...

Name: Z-1383-2016 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing...
Creator: Synthes (USA) Products LLC
Published: 2015-12-08
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-12-08 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is... on 2015-12-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1383-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-08
Posted: 2018-10-11
Terminated: 2016-08-26
Recalling firm: Synthes (USA) Products LLC
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.
Product code: GXQ Dura Substitute
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Siemens mailed out an Urgent: Field Safety Notification letter informing customers to review the replacement package insert (GP2715-C) and discard the outdated package insert (GP2715-B) and outdated promotional materials. Customers were asked to complete the verification section (page 3 of the recall notification) and send a copy of the completed Verification Section by Fax (888)912-7351 or Scan/Email to [email protected]
Quantity in commerce: 212 units
Distribution: Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts.
Product codes and lots: SYNTHECEL Dura Repair 2.5 cm x 2.5 cm (1x1), part numbers: SC.400.006.01S, Lot Numbers: 7840311, 7855336, 7860563, 7909569, 7922340, 7932410, 7984104

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1383-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1383-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-13
Z-1384-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-13
Z-1385-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-13
Z-1386-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-13
Z-1387-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-13

Product code GXQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)