Arthrex Suture Anchor Recall Due to Potential Breakage During Insertion
Arthrex is recalling Nano Corkscrew FT Suture Anchors because they may break during insertion. The recall covers 1,418 units distributed in the US and abroad.
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: The recall involves a medical device with a risk of harm (anchor breakage) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Arthrex, Inc. is recalling the Arthrex Suture Anchor, Nano Corkscrew FT (Part Number AR-1317FT). This medical device is used for soft tissue fixation to bone in the hand and wrist. The recall involves 1,308 units in the United States and 110 units outside the US.
The recall was initiated because the device may lead to anchor breakage during insertion. The affected lots are 10175216, 1075219, 10199557, and 10199558. Distribution was nationwide in the US and in Finland and Germany.
Healthcare providers and patients should stop using the affected devices and contact Arthrex, Inc. for further instructions.
The recalled product
- Product
- Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
- Manufacturer
- Arthrex, Inc.
- Category
- Medical Device — Orthopedic
- Hazard
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 (4)
- Lots #: 10175216
- 1075219
- 10199557
- and 10199558
Distribution
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