SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute D...
FDA Recall #Z-1387-2016 — Class II — December 8, 2015
Product Description
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.
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.
Recalling Firm
Synthes (USA) Products LLC — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
317 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.
Code Information
SYNTHECEL Dura Repair 10.0 cm x 12.0 cm (4x5), part numbers: SC.400.120.01S, Lot Numbers: 7840506, 7840507, 7840509, 7855341, 7855342, 7855343, 7855344, 7855345, 7855346, 7855347, 7855349, 7860570, 7880952, 7900041, 7909693, 7922344, 7932423, 7937109, 7984110, 7989071, 9803078, 9810917
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.