The Recall Desk

FDA (Devices) recall action 70166

Stryker Craniomaxillofacial Division recalled 4 products on 2015-02-18

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2015-02-18
Critical
0
Units
4,204

Why these products were recalled

Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location.

Potential for implant damage, implant cracking off/breaking intra-operatively.

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

1–4 of 4

  • SevereFDA (Devices)··2015-02-18

    Stryker Recalls MEDPOR BARRIER Sheets for Potential Deformation and Cracking

    Stryker is recalling MEDPOR BARRIER Sheets due to risks of deformation, cracking, and loss of adhesion during surgery.

    Product
    MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and M
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2015-02-18

    Stryker Recalls MEDPOR Titan Max Orbital Floor and Wall Implants

    Stryker is recalling MEDPOR Titan Max Orbital Floor and Wall implants due to incorrect barrier location and potential mix-ups with left-sided units.

    Product
    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial t
    Category
    Distribution
    33 states
  • SevereFDA (Devices)··2015-02-18

    Stryker Recalls MEDPOR Surgical Implants Due to Potential Intraoperative Damage

    Stryker is recalling MEDPOR Surgical Implants because they may crack or break during surgery. The recall affects 1,051 units distributed worldwide.

    Product
    MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and r
    Category
    Distribution
    33 states
  • SevereFDA (Devices)··2015-02-18

    Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks

    Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.

    Product
    MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER
    Category
    Distribution
    33 states