CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report

Integra External Fixation System Rocker Bottom recalled

Integra LifeSciences is recalling Integra External Fixation System Rocker Bottom, distributed in Colorado, District of Columbia, Florida, Indiana, Oklahoma, Virginia. The recall was initiated on 1 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # PN625.

Quantity recalled27 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-2296-2016
FDA event ID: 74583
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 1 Jul 2016
FDA classified: 27 Jul 2016
Reported: 3 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Mold
Device type: Other Medical Devices

Timeline

1 Jul 2016	Recall initiated by company
27 Jul 2016	Classified by FDA	+26 days
3 Aug 2016	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 silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

Product as listed by the FDA

Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.

Where it was distributed

Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.

Colorado District of Columbia Florida Indiana Oklahoma Virginia

Questions about this recall

Is Integra External Fixation System Rocker Bottom recalled?

Yes. Integra LifeSciences recalled Integra External Fixation System Rocker Bottom on 1 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2296-2016.

Why was it recalled?

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

Which lots are affected?

Lot # PN625.

Where was it sold?

Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.

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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