The Recall Desk

FDA (Devices) recall action 61717

Integra LifeSciences Corp. recalled 2 products on 2012-06-20

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
2012-06-20
Critical
0
Units
64

Why these products were recalled

The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,

The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,

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

  • LowFDA (Devices)··2012-06-20

    Integra Mozaik Putty Recalled for Incorrect Instructions for Use Translation

    Integra LifeSciences Corp. is recalling 42 units of Mozaik Putty because the Instructions for Use contain incorrect Spanish and French translations of the term 'bone marrow aspirate'.

    Product
    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2012-06-20

    Integra Mozaik Strip Recalled for Incorrect Instructions for Use Translation

    Integra LifeSciences Corp. is recalling Integra Mozaik Strip units because the Instructions for Use contain incorrect Spanish and French translations of the term "bone marrow aspirate."

    Product
    Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal
    Category
    Distribution
    0 states