CLASS II Device recall · Reported 18 Jul 2018 · FDA Enforcement Report

Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm recalled by Stryker

Stryker is recalling Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S, distributed in 7 states. The recall was initiated on 27 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 04546540673428; Lot code: K081639

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-2408-2018
FDA event ID: 80131
Recalling firm: Stryker, Selzach
Classification: Class II
Status: Terminated
Recall initiated: 27 Apr 2018
FDA classified: 10 Jul 2018
Reported: 18 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

27 Apr 2018	Recall initiated by company
10 Jul 2018	Classified by FDA	+74 days
18 Jul 2018	Published in enforcement report	+8 days

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

Reason for recall

The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

Where it was distributed

The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.

Alabama Florida Kentucky North Carolina Tennessee Utah Washington

Questions about this recall

Is Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S recalled?

Yes. Stryker recalled Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S on 27 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2408-2018.

Why was it recalled?

Which lots are affected?

GTIN: 04546540673428; Lot code: K081639

Where was it sold?

The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.

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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