Aesculap Flexible Orthopedic Instrument Tray Set Recalled for Breakage Risk
Aesculap, Inc. is recalling flexible orthopedic instrument tray sets because the shafts may break during surgery, potentially leaving fragments in patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of foreign body retention (fragments left in a patient) during surgery, which aligns with the 'Severe' criteria for significant injury risk or structural defects in medical devices.
Plain-English summary
Aesculap, Inc. is recalling tray sets containing multiple orthopedic instruments, which may include flexible bone awls, flexible drills, and/or flexible screw drivers. These instruments are intended for use during the implantation of the A-Space SIBD and Arcadius XP L systems. The specific tray catalog number is ST0485-037, and the tray sets are not sealed.
The recall is being issued because the flexible shaft of the instruments may break during orthopedic spinal surgery. This defect poses a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. All lots are included in this recall. Healthcare facilities should stop using these instruments and contact Aesculap, Inc. for instructions on returning the products.
The recalled product
- Product
- Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and
- Manufacturer
- Aesculap, Inc.
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Aesculap, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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