Wright Medical Stryker DARCO Screw Recall: Incorrect Product in Packaging
Wright Medical recalls Stryker DARCO Screw (REF DC2825016) due to incorrect product in packaging. Affected units may contain wrong item; contact for details.
Lower-risk recall
The incorrect product is contained in the packaging.
Contact the company
What happened, in plain English
Wright Medical is recalling a specific Stryker DARCO Screw model because it was incorrectly packaged. This means some buyers might have received the wrong screw, which could lead to improper use in medical procedures. Read more at govinfonow.com/recall/61471-wright-medical-stryker-darco-screw-recall-incorrect-product-in-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/61471-wright-medical-stryker-darco-screw-recall-incorrect-product-in-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0393-2022
Cite this page
“Wright Medical Stryker DARCO Screw Recall: Incorrect Product in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61471-wright-medical-stryker-darco-screw-recall-incorrect-product-in-packaging. Based on FDA recall #Z-0393-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0393-2022%22&limit=1).
Why it’s dangerous
The recall states that the incorrect product is in the packaging. This means the wrong screw could be used in medical procedures, potentially causing improper fixation or complications during surgery.
Who’s affected
Medical professionals and facilities that purchased the Stryker DARCO Screw (REF DC2825016) with lot number 1643355 are likely affected. Those using the product for surgical procedures are at the highest risk.
How to tell if you have this one
Check for the product name 'Stryker DARCO Screw, Locking, Ti6A14V' with reference number DC2825016 and lot number 1643355 on the packaging.
- Brand
Wright Medical- 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
Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0392-2022 | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.; Lot #1642103 | 23 units |
| Z-0393-2022 | Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.; Lot #1643355 | 250 units |
What to do — step by step
Check Packaging
Verify the product name, reference number DC2825016, and lot number 1643355 on the packaging to confirm if it's the recalled item.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
FDA distribution: “Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Idaho, Iowa, New York, North Carolina, Virginia, West Virginia.
Recall timeline
FDA published this recall 26 days 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-0393-2022 (December 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0393-2022 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.