Stryker Nail Insertion Sleeve Recall: Incorrect Size Labeling Risk
Stryker recalls elastic T2 Tibia SPI sleeves with incorrect inner diameter labeling. This may cause improper nail insertion. Affected units have specific catalog and lot numbers.
Lower-risk recall
The devices have a different inner diameter than the diameter specified on the outer box label.
Contact the company
What happened, in plain English
Stryker is recalling elastic T2 Tibia SPI nail insertion sleeves that have a different inner diameter than what's labeled on the box. This could lead to improper nail insertion if used without checking the actual size. Read more at govinfonow.com/recall/62468-stryker-nail-insertion-sleeve-recall-incorrect-size-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62468-stryker-nail-insertion-sleeve-recall-incorrect-size-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2170-2021
Cite this page
“Stryker Nail Insertion Sleeve Recall: Incorrect Size Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62468-stryker-nail-insertion-sleeve-recall-incorrect-size-labeling-risk. Based on FDA recall #Z-2170-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2170-2021%22&limit=1).
Why it’s dangerous
The sleeves have an inner diameter that doesn't match the label on the outer box. This mismatch could cause improper nail insertion if the sleeve is used without verifying the actual size. However, the hazard does not involve immediate injury risks.
Who’s affected
Orthopedic surgeons and medical professionals using these sleeves for nail insertion procedures. The risk is low as the hazard involves a size mismatch rather than immediate danger.
How to tell if you have this one
Check for the catalog number 18061407S and lot number K03CC50 on the product. The product is sold under the name 'Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13).
- Brand
Stryker- Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S- Category
Medical device
All 2 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
Ongoing- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2170-2021 | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S; GTIN 07613327005417, Lot Number K03CC50 | 52 |
| Z-2171-2021 | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S; GTIN 04546540715357, Lot Number K03CC4F | 242 |
What to do — step by step
Check Product Label
Look for the catalog number 18061407S and lot number K03CC50 on the sleeve.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-2170-2021 (May 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2170-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.