Stryker Osteosynthesis Screws Recalled Due to Safety Concerns
Summary
The French ANSM has announced a recall of Stryker osteosynthesis screws (7.0 mm Darco headless screws, 16x60 mm) due to safety concerns. This action, registered under recall number R2606623, affects pharmacies and users who have received direct communication from Stryker Instruments.
What changed
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety recall for specific Stryker osteosynthesis screws, identified as 7.0 mm Darco headless screws, size 16x60 mm. This recall, designated R2606623, was initiated by Stryker Instruments and is being communicated to relevant healthcare facilities, particularly pharmacies. The specific reason for the recall is related to safety concerns, prompting a withdrawal of affected lots from circulation.
Healthcare providers, especially pharmacies, that may have received or stocked these specific Stryker screws must immediately cease their use and follow the instructions provided by Stryker Instruments. While the document does not specify a compliance deadline for the recall itself, it directs all inquiries to the manufacturer. Failure to comply with product recalls can lead to patient safety risks and potential regulatory scrutiny.
What to do next
- Identify and quarantine affected Stryker 7.0 mm Darco headless osteosynthesis screws (16x60 mm).
- Cease use of recalled product.
- Follow instructions provided by Stryker Instruments for return or disposition.
Source document (simplified)
Rappel n° R2606623 destiné aux pharmacies d'usage intérieur Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606623. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.
L'ANSM a été informée de la mise en œuvre d’une action de retrait de lot effectuée par la société Stryker Instruments.
Les utilisateurs concernés ont reçu le courrier ci-joint. Téléchargez le courrier de la société Stryker Instruments (16/03/2026)
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