The Recall Desk

FDA (Devices) recall action 87293

Corin Ltd recalled 2 products on 2021-03-31

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
2021-03-31
Critical
0
Units
46

Why these products were recalled

The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

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)··2021-03-31

    Corin Trinity Hip Prosthesis Heads Recalled for Incorrect Size Labeling

    Corin Ltd is recalling 23 units of Trinity Biolox Delta Ceramic Heads due to incorrect size labeling on packaging and patient stickers.

    Product
    Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-03-31

    Corin Trinity Acetabular System Recalled for Incorrect Size Labeling

    Corin Ltd is recalling 23 units of the Trinity Acetabular System because the size indicated on the packaging and patient stickers is incorrect.

    Product
    Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit…
    Category
    Distribution
    0 states