The Recall Desk

FDA (Devices) recall action 81087

Stryker GmbH recalled 4 products on 2018-11-07

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
2018-11-07
Critical
0
Units
3,632

Why these products were recalled

The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.

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

  • SevereFDA (Devices)··2018-11-07

    Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

    Stryker GmbH is recalling 867 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the medical device.

    Product
    Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
    Category
    Distribution
    7 states
  • SevereFDA (Devices)··2018-11-07

    Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

    Stryker GmbH is recalling 1,355 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising frame stability.

    Product
    Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
    Category
    Distribution
    7 states
  • SevereFDA (Devices)··2018-11-07

    Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

    Stryker GmbH is recalling 832 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.

    Product
    Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
    Category
    Distribution
    7 states
  • SevereFDA (Devices)··2018-11-07

    Stryker Recalls Hoffmann LRF Hexapod Struts Due to Pin Fit Defect

    Stryker GmbH is recalling 578 Hoffmann LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.

    Product
    Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
    Category
    Distribution
    7 states