The Recall Desk

FDA (Devices) recall action 63338

Wright Medical Technology Inc recalled 3 products on 2012-11-07

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2012-11-07
Critical
0
Units
33,135

Why these products were recalled

There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

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.

1–3 of 3

  • ModerateFDA (Devices)··2012-11-07

    Wright Medical Recalls Extremity Components Due to Shelf Life Labeling Errors

    Wright Medical Technology Inc. is recalling 840 units of orthopaedic extremity components because the labeled shelf life may be inaccurate for products packaged in Toulon, France.

    Product
    Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X0941898
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-07

    Wright Medical Recalls Knee Components Due to Shelf Life Labeling Errors

    Wright Medical Technology Inc is recalling 729 knee components due to potential inaccuracies in labeled shelf life at the Toulon, France facility.

    Product
    Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-11-07

    Wright Medical Recalls Hip Components Due to Potential Shelf Life Labeling Errors

    Wright Medical Technology Inc. is recalling 31,566 hip implant components distributed worldwide due to potential inaccuracies in labeled shelf life.

    Product
    Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMU
    Category
    Distribution
    0 states