The Recall Desk
HighFDA (Devices)·Z-1386-2016·Announced 2016-04-20

Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks During Removal

Synthes (USA) Products LLC is recalling 378 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures 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 is classified as FDA Class II. The hazard involves a risk of harm (adhesion to anatomical structures) during a specific surgical procedure (removal), but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Synthes (USA) Products LLC is recalling 378 units of SYNTHECEL Dura Repair, a Class II medical device intended for use as a dura replacement in adults. The recall was initiated after reports indicated that the device could adhere to various anatomical structures post-implantation. This adhesion presents potential risks if a surgeon intends to temporarily apply and subsequently remove the implant.

The affected product is the SYNTHECEL Dura Repair 7.5 cm x 7.5 cm (3x3) size, with part number SC.400.056.01S. The recall covers specific lot numbers: 7840501, 7855340, 7860569, 7880951, 7900040, 7909689, 7922343, 7932422, 7937107, 9800722, 9813796, and 9862235. 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 involved.

To address this issue, Synthes is updating the labeling and promotional material for SYNTHECEL Dura Repair. The updates will clarify that the device is intended to remain in place permanently and is not intended to be removed. Healthcare providers and patients should be aware that the device is designed for 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
378

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 (14)

  • SYNTHECEL Dura Repair 7.5 cm x 7.5 cm (3x3)
  • part numbers: SC.400.056.01S
  • Lot Numbers: 7840501
  • 7855340
  • 7860569
  • 7880951
  • 7900040
  • 7909689
  • 7922343
  • 7932422
  • 7937107
  • 9800722
  • 9813796
  • 9862235

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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