The Recall Desk

FDA (Devices) recall action 72229

Encore Medical, Lp recalled 2 products on 2015-11-04

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
2015-11-04
Critical
0
Units
911

Why these products were recalled

During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

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.

1–2 of 2

  • ModerateFDA (Devices)··2015-11-04

    Encore Medical Recalls Reverse Shoulder Prosthesis Stem Impaction Fixtures

    Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.

    Product
    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then…
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    0 states
  • HighFDA (Devices)··2015-11-04

    Encore Medical Recalls Turon Shoulder Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 277 Turon Shoulder Impaction Fixtures because polymer material wore off during assembly, potentially contaminating the implant.

    Product
    Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to…
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    Distribution
    0 states