The Recall Desk
HighFDA (Devices)·Z-1364-2015·Announced 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.

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 failure of sterile packaging creates a potential for infection, but the source text does not report any actual injuries or illnesses.

Plain-English summary

Biomet, Inc. is recalling 50 units of Ziploop Buttons and ToggleLocs manufactured in May and July 2014. The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedures due to injury or degenerative disease. The recall is limited to units with Product Number 110010873 and Lot 209340.

The recall was initiated because the devices were not processed following a standard work process, which resulted in complaints that the sterile packaging was not sealed. This defect compromises the sterility of the medical devices.

The affected units 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 units and contact Biomet, Inc. for instructions on return or replacement.

The recalled product

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
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
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: 110010873 Lot: 209340

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 →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · sterility failure

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