Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1383-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 8, 2015

Date Posted: April 20, 2016

Recall Number: Z-1383-2016

Event ID: 73559

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.

Status: Terminated

Product Quantity: 212 units

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated