The Recall Desk

FDA (Devices) recall action 70667

Biomet, Inc. recalled 2 products on 2015-04-08

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
2015-04-08
Critical
0
Units
100

Why these products were recalled

The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.

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

1–2 of 2

  • HighFDA (Devices)··2015-04-08

    Biomet Recalls ToggleLoc and Ziploop Fixation Devices Due to Packaging Defects

    Biomet is recalling ToggleLoc and Ziploop devices manufactured in 2014 because sterile packaging was not sealed, potentially compromising sterility.

    Product
    ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring s
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2015-04-08

    Biomet Recalls Ziploop Button and ToggleLocs Due to Packaging Seal Issues

    Biomet, Inc. is recalling 50 units of Ziploop Buttons and ToggleLocs manufactured in 2014 because sterile packaging was not properly sealed.

    Product
    Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
    Category
    Distribution
    5 states