Aesculap Flexible Drill Recalled Due to Potential Shaft Breakage During Surgery
Aesculap, Inc. is recalling 13 Flexible Drill instruments (SJ723R) because the flexible shaft may break during orthopedic spinal surgery, posing a risk of surgical delay or retained fragments.
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. The hazard involves a medical device breaking during surgery, which could result in a fragment being left in a patient, constituting a significant injury risk.
Plain-English summary
Aesculap, Inc. is recalling 13 units of the Flexible Drill (model SJ723R, non-sterile). These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. The recall covers all lots of this product.
The recall is being conducted because the flexible shaft of the instruments may break during orthopedic spinal surgery. This defect presents a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
The products were distributed nationwide in the United States and in Canada. Healthcare facilities and consumers should stop using these instruments and contact Aesculap, Inc. for further instructions.
The recalled product
- Product
- Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
- Manufacturer
- Aesculap, Inc.
- Affected units
- 13
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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