The Recall Desk

FDA (Devices) recall action 76694

Medtronic Sofamor Danek USA Inc recalled 4 products on 2017-03-29

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
2017-03-29
Critical
0
Units
255

Why these products were recalled

The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

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

  • HighFDA (Devices)··2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic Sofamor Danek USA Inc is recalling 72 units of Poly Component Trial knee implants because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial…
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2017-03-29

    Medtronic Recalls Poly Component Trials Due to Cracked or Broken Dovetails

    Medtronic is recalling 111 units of Poly Component Trials because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic is recalling Poly Component Trial knee implants because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10…
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic is recalling 72 Poly Component Trial knee implants because their dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF…
    Category
    Distribution
    2 states