The Recall Desk
HighFDA (Devices)·Z-1387-2016·Announced 2016-04-20

Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

Synthes (USA) Products LLC is recalling 317 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

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 medical device where the hazard (adhesion leading to potential injury during removal) is present, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Synthes (USA) Products LLC is recalling 317 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 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 10.0 cm x 12.0 cm (4x5) size, part number SC.400.120.01S. The recall covers specific lot numbers including 7840506, 7840507, 7840509, 7855341, 7855342, 7855343, 7855344, 7855345, 7855346, 7855347, 7855349, 7860570, 7880952, 7900041, 7909693, 7922344, 7932423, 7937109, 7984110, 7989071, 9803078, and 9810917. The devices were distributed nationwide to accounts in 32 states, including New York, Pennsylvania, and California, with no foreign accounts affected.

To address this issue, Synthes is updating the labeling and promotional material for SYNTHECEL Dura Repair. The updates 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 — Neurological / Dura Substitute
Hazard
Affected units
317

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 (20)

  • 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

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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