Lower risk Medical device recall · FDA · Published April 27, 2018

Stryker Femoral Nail Recall: Risk of Premature Breakage

Stryker recalls certain Femoral Nails (A/R T2 Femur 10x320 mm) due to potential reduced strength causing premature breakage. Affected units have specific product numbers and lot codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2394-2018Medical device Stryker ›

Lower-risk 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.

Take action

Contact the company

Recalling firmStryker GmbHBohnackerweg 1 · Selzach, Switzerland

✎ GovInfoNow plain-language explainer

Stryker is recalling specific femoral nails that may have weaker strength, increasing the risk of breaking during use. This could lead to complications in medical procedures if the nail fractures unexpectedly. Read more at govinfonow.com/recall/71266-stryker-femoral-nail-recall-risk-of-premature-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/71266-stryker-femoral-nail-recall-risk-of-premature-breakage · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2394-2018

Cite this page

“Stryker Femoral Nail Recall: Risk of Premature Breakage.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71266-stryker-femoral-nail-recall-risk-of-premature-breakage. Based on FDA recall #Z-2394-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2394-2018%22&limit=1).

The FDA announced on April 27, 2018, that Stryker GmbH recalled one Femoral Nail due to potentially out-of-specification manufacturing. Non-conforming cannulation may result in reduced component strength and premature nail breakage.

How to tell if you have it

Brand: Stryker
Product: Femoral Nail, A/R T2 Femur ¿10x320 mm
Product Number: 18251032S
UPC: 04546540199492
Lot code: K081642

The hazard

The manufacturer 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.

Context

GovInfoNow's records show Stryker GmbH has 20 other recalls on record since 2018-03-12. Recent Stryker recalls include a July 1, 2026 notice for Hoffmann II Connecting Rods regarding potential cracking and May 28, 2025 and May 22, 2025 notices for Gamma4 Right Long Nails and T2 Greater Trochanter Nails involving wrong geometry or type. Other recent recalls of similar products include Zimmer Affixus Antegrade Femoral Nails (Dec. 2, 2025), Zimmer Affixus Femoral Nails (Dec. 2, 2025) and Zimmer Affixus Femoral Nails (Dec. 2, 2025).

How to tell if you have this one

Check for the product number 18251032S, lot code K081642, or GTIN 04546540199492 on the nail packaging. These items were sold with specific dates and locations.

Brand
Stryker
Product
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
Category
Medical device

FDA recall event · 16 products

All 16 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.

Recall number	Product, codes & lots	Quantity
Z-2393-2018	Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S; GTIN 04546540197771; Lot code: K074846	12
Z-2394-2018	Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S; GTIN 04546540199492; Lot code: K081642	2
Z-2395-2018	Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S; GTIN 04546540199508; Lot code: K0957B1	17
Z-2396-2018	Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S; GTIN 04546540199775; Lot code: K081650	9
Z-2397-2018	Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S; GTIN 04546540200105; Lot code: K078C70	1
Z-2398-2018	Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S; GTIN 04546540200402; Lot code: K08327D	7
Z-2399-2018	Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S; GTIN: 04546540200655; Lot code: K07AFF5	—
Z-2400-2018	Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S; GTIN: 04546540200686; Lot code: K076A7C	—
Z-2401-2018	Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S; GTIN: 04546540200693; Lot code: K08327F	—
Z-2402-2018	Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S; GTIN: 04546540646583; Lot code: K08D58D	—
Z-2403-2018	Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S; GTIN: 04546540646842; Lot code: K081650	—
Z-2404-2018	Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S; GTIN: 04546540647078; Lot code: K078C74	—
Z-2405-2018	Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S; GTIN: 04546540647320; Lot code: K076A80	—
Z-2406-2018	Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S; GTIN: 07613252129295; Lot code: K0748D3	—
Z-2407-2018	Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S; GTIN: 04546540673398; Lot code: K078C7E	—
Z-2408-2018	Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S; GTIN: 04546540673428; Lot code: K081639	—

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product number, lot code, and GTIN on the nail packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed in 8 states.

FDA distribution: “The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, Washington.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Apr 27, 2018Firm started the recall
Jul 10, 2018FDA classified it Class II
Jul 18, 2018Published in FDA’s Enforcement Report
May 21, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71266-stryker-femoral-nail-recall-risk-of-premature-breakage">Stryker Femoral Nail Recall: Risk of Premature Breakage (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2394-2018 (April 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2394-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.