The Recall Desk
HighFDA (Devices)·Z-1385-2016·Announced 2016-04-20

Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risk

Synthes (USA) Products LLC is recalling 289 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if a surgeon attempts to remove it.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the hazard is the potential for injury during a non-intended removal procedure, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Synthes (USA) Products LLC is recalling 289 units of SYNTHECEL Dura Repair, a Class II medical device intended for use as a dura replacement in adults. The recall is being conducted because the device was reported to adhere to various anatomical structures after implantation. This adhesion may expose patients to potential risks if a surgeon intends to temporarily apply and subsequently remove the implant.

The affected product is the SYNTHECEL Dura Repair 5.0 cm x 5.0 cm (2x2) size, with part number SC.400.025.01S. The recall covers specific lot numbers: 7840495, 7855339, 7860566, 7880950, 7900039, 7909573, 7922342, 7932416, and 7984107. The devices were distributed nationwide to accounts in New York, Pennsylvania, Alabama, Wisconsin, Florida, Missouri, Tennessee, Ohio, Michigan, Minnesota, Colorado, California, Nevada, Arizona, Louisiana, Oregon, Texas, Iowa, Indiana, Mississippi, Illinois, Arkansas, West Virginia, Hawaii, Virginia, Maryland, Washington, Oklahoma, Massachusetts, Kentucky, New Jersey, and Connecticut. No foreign accounts were affected.

To address this issue, Synthes is updating the labeling and promotional material for SYNTHECEL Dura Repair. The updated materials will clarify that the device is intended to remain in place permanently and is not intended to be removed. Healthcare providers and patients should review the updated labeling to ensure the device is used in accordance with its intended permanent implantation.

The recalled product

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.
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Dura Substitute
Hazard
Affected units
289

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Synthes (USA) Products LLC

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Same hazard · adhesion

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