CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report

Ziploop Button recalled by Biomet

Biomet is recalling Ziploop Button, distributed nationwide in the US. The recall was initiated on 26 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPN: 110010873 Lot: 209340

Quantity recalled50 Units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1364-2015
FDA event ID: 70667
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 26 Feb 2015
FDA classified: 1 Apr 2015
Reported: 8 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

26 Feb 2015	Recall initiated by company
1 Apr 2015	Classified by FDA	+34 days
8 Apr 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.

Nationwide Georgia North Carolina New Mexico Oklahoma Texas

Questions about this recall

Is Ziploop Button recalled?

Yes. Biomet recalled Ziploop Button on 26 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-1364-2015.

Why was it recalled?

Which lots are affected?

PN: 110010873 Lot: 209340

Where was it sold?

Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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