The Recall Desk

FDA (Devices) recall action 63230

Synthes USA HQ, Inc. recalled 2 products on 2013-12-04

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
2013-12-04
Critical
0
Units
1,502

Why these products were recalled

This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.

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

  • HighFDA (Devices)··2013-12-04

    Synthes Polyaxial Screw Body Recalled for Potential Post-Operative Loosening

    Synthes USA is recalling 757 units of Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bodies due to reported complaints of post-operative locking cap loosening.

    Product
    Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
    Category
    Distribution
    27 states
  • HighFDA (Devices)··2013-12-04

    Synthes Titanium Spinal Locking Caps Recalled for Post-Operative Loosening

    Synthes USA is recalling 745 Titanium Minimally Invasive Reduction Screw System Locking Caps due to a risk of post-operative loosening if the construct is mis-aligned during final tightening.

    Product
    Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
    Category
    Distribution
    27 states