FDAFDA · Food and drugs·Recall number Z-1385-2016
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.
Published April 20, 2016 · Recall initiated: December 8, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- 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.
- Lot
- SYNTHECEL Dura Repair 5.0 cm x 5.0 cm (2x2), part numbers: SC.400.025.01S, Lot Numbers: 7840495, 7855339, 7860566, 7880950, 7900039, 7909573, 7922342, 7932416, 7984107
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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