—#144459

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.

FDA product code: GXQ — Dura Substitute
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K113071, K131792
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Labeling False and Misleading

Action the firm took

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Safety Notification letter informing customers to review the replacement package insert (GP2715-C) and discard the outdated package insert (GP2715-B) and outdated promotional materials.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 Synthes5875@stericycle.com

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

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.

Timeline

Recall initiated: 2015-12-08
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.