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

Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm recalled by Stryker

Stryker is recalling Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S, 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: 04546540673398; Lot code: K078C7E

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-2407-2018
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 ¿10x300mm, Product Number 18191030S

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

Why was it recalled?

Which lots are affected?

GTIN: 04546540673398; Lot code: K078C7E

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

Other products in this recall event

15 other products · FDA event 80131

This product is part of a recall event; the main page for the event is Femoral Nail, A/R T2 Femur ¿ mm, Product Number 18251032S recalled.

Reported	Class	Recall	Company	Reason	Where
18 Jul 2018	CLASS II	Femoral Nail, A/R T2 Femur ¿ mm, Product Number 18251032S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, A/R, R1500 T2 Femur ¿ mm, Product Number 18281230S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, A/R, R1500 T2 Femur ¿ mm, Product Number 18281236S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, LEFT T2 GTN ¿ mm, Product Number 18501430S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, Right T2 GTN ¿ mm, Product Number 18511446S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm recalled by Stryker	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, A/R T2 Femur ¿ mm, Product Number 18251034S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, A/R T2 Femur ¿ mm, Product Number 18251524S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, LEFT T2 GTN ¿ mm, Product Number 18501036S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, A/R, R1500 T2 Femur ¿ mm, Product Number 18281032S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, Right T2 GTN ¿ mm, Product Number 18510932S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Tibial Nail, Standard T2 Tibia ¿ mm, Product Number 18221231S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, LEFT T2 GTN ¿ mm, Product Number 18501236S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, A/R, R1500 T2 Femur ¿ mm, Product Number 18281238S recalled	Stryker	Device Malfunction	7 states
18 Jul 2018	CLASS II	Femoral Nail, A/R T2 Femur ¿ mm, Product Number 18251236S recalled	Stryker	Device Malfunction	7 states

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