The Recall Desk

FDA (Devices) recall action 73559

Synthes (USA) Products LLC recalled 5 products on 2016-04-20

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2016-04-20
Critical
0
Units
1,396

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··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.

    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.
    Category
    Distribution
    32 states
  • HighFDA (Devices)··2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 212 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    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.
    Category
    Distribution
    32 states
  • HighFDA (Devices)··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.

    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.
    Category
    Distribution
    32 states
  • HighFDA (Devices)··2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 200 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    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.
    Category
    Distribution
    32 states
  • HighFDA (Devices)··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.

    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.
    Category
    Distribution
    32 states