The Recall Desk

FDA (Devices) recall action 75892

Stanmore Implants Worldwide Ltd. recalled 5 products on 2016-12-28

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2016-12-28
Critical
0
Units
105

Why these products were recalled

The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

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

1–5 of 5

  • ModerateFDA (Devices)··2016-12-28

    Stanmore Implants Recalls DF Coated Integral Shaft and Stem Components

    Stanmore Implants Worldwide Ltd. is recalling 15 units of DF Coated Integral Shaft & Stem components due to packaging punctures reported by customers.

    Product
    DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or…
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2016-12-28

    Stanmore Tibial Component Fixed Hinge Recall Due to Pouch Puncture

    Stanmore Implants Worldwide Ltd. is recalling 13 units of Tibial Component Fixed Hinge Small Long and Short due to punctured packaging.

    Product
    Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2016-12-28

    Stanmore Implants Recalls Punctured Femoral Shaft Components

    Stanmore Implants Worldwide Ltd. is recalling 11 femoral shaft components due to punctured packaging reported by customers.

    Product
    Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2016-12-28

    Stanmore Implants Recalls Punctured Femoral Stem Components

    Stanmore Implants Worldwide Ltd. is recalling 15 femoral stem components because customer inquiries reported that the device stem punctured the packaging pouch.

    Product
    Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if…
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2016-12-28

    Stanmore Implants Recalls Tibial Components Due to Packaging Puncture

    Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.

    Product
    Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the…
    Category
    Distribution
    11 states