The Recall Desk

FDA (Devices) recall action 75234

Zimmer Biomet, Inc. recalled 2 products on 2016-10-19

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-10-19
Critical
0
Units
62

Why these products were recalled

Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the su…

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

1–2 of 2

  • ModerateFDA (Devices)··2016-10-19

    Zimmer Biomet Recalls Phoenix Recon Soft Tissue Sleeve Guide Instruments

    Zimmer Biomet is recalling 31 Phoenix Recon Soft Tissue Sleeve Guides due to incompatibility with new revision targeting arms, which may cause surgical delays.

    Product
    Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused…
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2016-10-19

    Zimmer Biomet Recalls Phoenix Recon Targeting Arm Surgical Instruments

    Zimmer Biomet is recalling 31 Phoenix Recon Targeting Arm surgical instruments because old and new revisions are not interchangeable, potentially causing surgical delays.

    Product
    Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by…
    Category
    Distribution
    10 states