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.
FDA Recall Z-1383-2016 · Posted None
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Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeGXQ
Date Initiated2015-12-08
Date Terminated2016-08-26
Product Quantity212 units
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.
Firm 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Safety Notification letter informing customers to review the replacement package insert (GP2715-C) and discard the outdated package insert (GP2715-B) and outdated promotional materials.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]
Root Cause
Labeling False and Misleading
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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