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U.S. Department of Health and Human Services

Class 2 Device Recall SYNTHECEL Dura Repair

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 Class 2 Device Recall SYNTHECEL Dura Repairsee related information
Date Initiated by FirmDecember 08, 2015
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on August 26, 2016
Recall NumberZ-1383-2016
Recall Event ID 73559
510(K)NumberK113071 K131792 
Product Classification Dura substitute - Product Code GXQ
ProductSYNTHECEL 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.
Code Information 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
FEI Number 3008812560
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactDavid Carvin
610-719-5443
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionSiemens 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Safety Notification letter informing customers to review the replacement package insert (GP2715-C) and discard the outdated package insert (GP2715-B) and outdated promotional materials.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 Synthes5875@stericycle.com
Quantity in Commerce212 units
DistributionNationwide: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GXQ
510(K)s with Product Code = GXQ
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