Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1387-2016)

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-1387-2016

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: 317 units

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

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