The Recall Desk
HighFDA (Devices)·Z-1363-2015·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the sterile packaging was not sealed, creating a potential infection risk, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Biomet, Inc. is recalling ToggleLoc and Ziploop artificial ligament fixation devices manufactured in May and July 2014. The recall is due to a manufacturing error where the products were not processed according to standard work procedures, resulting in complaints that the sterile packaging was not sealed.

The affected products are non-resorbable systems intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation. The recall involves 50 units of each product type. The devices were distributed nationwide in the United States, specifically in Texas, Georgia, New Mexico, North Carolina, and Oklahoma, as well as in Japan and the Netherlands.

Healthcare providers and patients should stop using these specific devices and contact Biomet, Inc. for further instructions or replacement. The specific product numbers and lot numbers involved are PN: 904755 Lot: 019150 and PN: 909848 Lot: 729530.

The recalled product

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
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Fixation
Hazard
Affected units
50

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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