Medartis AG recalled the 2.5 TriLock Screw 16mm HD7, 1/Pkg, sold worldwide through medical distributors including the US states of Indiana and Pennsylvania. The recall stems from a mix-up between 2.5mm and 2.8mm outer diameter screws. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medartis AG or your healthcare provider for instructions. Notification method: Letter
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The APTUS/Medartis fixation system is used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. The subject screw is a 2.5 TriLock locking screw used in various fixation procedures.
A mix-up between 2.5mm and 2.8mm outer diameter screws could result in selecting an incorrect screw size during a fixation procedure, potentially affecting implant stability.
This recall is not part of a broader industry pattern.
The issue requires clinical review and potential re-operation if mis-sized screws were used. No injuries have been reported to date, but the possibility of implant-related complications exists until the device is removed or replaced per instructions.
Identify numbers on device packaging and inserts; Model A-5750.16/1; Lot 25472432
4-6 weeks for refund or replacement processing in typical cases
Keep recall notices, packaging, lot numbers, photos, and all correspondence with supplier or hospital records for future reference
Model/Catalog Number: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm Lot Code: 25472432 Distribution: Worldwide; US distribution includes Indiana and Pennsylvania; Countries cited: Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, Poland Sold at: Unknown Price: Unknown Date Sold: Unknown
No injuries or incidents have been reported.
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