The Recall Desk

FDA (Devices) recall action 73981

Zimmer Manufacturing B.V. recalled 12 products on 2016-05-25

The FDA (Devices) publishes a recall like this one as 12 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 12 pages.

Products
12
Announced
2016-05-25
Critical
0
Units
11,400

Why these products were recalled

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

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.

1–12 of 12

  • HighFDA (Devices)··2016-05-25

    Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific lots of Herbert Cannulated Bone Screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
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    0 states
  • HighFDA (Devices)··2016-05-25

    Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws

    Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

    Product
    Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm…
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    0 states
  • ModerateFDA (Devices)··2016-05-25

    Zimmer Manufacturing Recalls Trilogy Self-Tapping Bone Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of Trilogy self-tapping bone screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
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    Distribution
    0 states
  • HighFDA (Devices)··2016-05-25

    Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws

    Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

    Product
    M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-05-25

    Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise

    Zimmer Manufacturing B.V. is recalling specific lots of 3.5 mm Cortical Screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401…
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    0 states
  • ModerateFDA (Devices)··2016-05-25

    Zimmer Manufacturing Recalls Mini MagnaFx Cannulated Bone Screws

    Zimmer Manufacturing B.V. is recalling specific lots of Mini MagnaFx and MagnaFx cannulated bone screws due to a potential small hole in the inner tray of the sterile packaging.

    Product
    Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini…
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    0 states
  • ModerateFDA (Devices)··2016-05-25

    Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile hip and trauma implant screws because a small hole may be present in the inner tray.

    Product
    ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-05-25

    Zimmer 2.7 mm Cortical Screws Recalled for Potential Tray Hole

    Zimmer Manufacturing B.V. is recalling specific lots of 2.7 mm Cortical Screws because a small hole may be present in the inner tray of the sterile packaging.

    Product
    Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-05-25

    Zimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific lots of VersaFx Femoral Fixation System screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-05-25

    Zimmer Manufacturing Recalls Hip and Trauma Implant Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

    Product
    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone…
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    0 states
  • ModerateFDA (Devices)··2016-05-25

    Zimmer Universal Locking System Cortical Screws Recalled for Packaging Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile hip and trauma implant screws because a small hole may be present in the inner tray.

    Product
    Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
    Category
    Distribution
    0 states