APTUS 2.8 TriLock Bone Fixation Screws Recalled for Incorrect Length
Medartis Inc. is recalling APTUS 2.8 TriLock Screws (lot 24377397) because some units are 16mm long instead of the specified 22mm, which could compromise bone fixation stability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II device with a dimensional defect that could result in implant failure, but no hospitalizations or injuries have been reported. This meets the rubric criteria for Score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medartis Inc. is recalling APTUS 2.8 TriLock Screws, metal bone fixation fasteners used with the APTUS fixation system. Affected units are part number A-5850.22/1, UDI-DI 76300378022PA, lot number 24377397.
An investigation determined that screws in the recalled lot are 16mm long instead of the specified 22mm. This dimensional defect could potentially affect the proper seating and stability of the implant during bone fixation procedures.
The recall affects 110 units distributed worldwide. US distribution is limited to Texas, and international distribution includes Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, and Switzerland.
The recalled product
- Product
- APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
- Manufacturer
- Medartis Inc.
- Affected units
- 110
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 (3)
- Part No. A-5850.22/1
- UDI-DI: 76300378022PA
- Lot No. 24377397.
Distribution
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