Medartis APTUS TriLock screw lots mixed 2.5 mm and 2.8 mm
Medartis is recalling one lot of the APTUS 2.8 TriLock Screw 16 mm because of a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers low-risk, precautionary recalls: the fault is a mix-up between two screw sizes rather than a defect, and the source describes no hazard, illness or injury.
Plain-English summary
Medartis AG is recalling the APTUS 2.8 TriLock Screw 16mm, HD7, model A-5850.16/1. The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. About 126 units were distributed in Indiana and Pennsylvania, and to Austria, Belgium, Switzerland, the Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan and Poland. The FDA has classified this recall as Class II.
There was a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws. The source record does not describe a defect in the screws themselves.
Affected product is lot 25467933.
Facilities can identify affected screws by the model number and lot above, and may contact Medartis AG for further information.
The recalled product
- Product
- Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
- Manufacturer
- Medartis AG
- Hazard
- product-mixup
- wrong-size
- labelling-error
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 (2)
- HD7
- 1/Pkg Lot: 25467933
Distribution
Distributed nationwide across the United States.
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