Stryker DARCO Screw Recall: Incorrect Product in Packaging
Wright Medical Technology Inc is recalling 250 units of Stryker DARCO Screws (Lot #1643355) because the incorrect product was found in the packaging. Affected units were distributed across multiple U.S. states and countries worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an orthopedic surgical implant where incorrect product packaging poses a risk of adverse health consequences. No specific illnesses or injuries are reported in the source text, placing the score at High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Wright Medical Technology Inc is recalling the Stryker DARCO Screw, Locking, Ti6A14V (REF DC2825016, 2.7mm x 16mm). The recall affects 250 units identified with Lot #1643355. The reason for the recall is that an incorrect product has been found in the packaging.
The affected products were distributed worldwide. In the United States, distribution occurred in Arizona, Iowa, Idaho, North Carolina, New York, Virginia, and West Virginia. Internationally, the products were distributed to Canada, France, Germany, Lebanon, the Netherlands, Saudi Arabia, and the United Kingdom.
Healthcare providers and patients who have received this product should stop using it. They should contact Wright Medical Technology Inc immediately for return instructions or to obtain a replacement with the correct product.
The recalled product
- Product
- Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
- Manufacturer
- Wright Medical Technology Inc
- Affected units
- 250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #1643355
Distribution
Part of a larger recall action
This product is one of 2 recalled by Wright Medical Technology Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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