The Recall Desk
HighFDA (Devices)·Z-0423-2016·Announced 2015-12-30

Aesculap Flexible Bone Awl Recalled for Potential Shaft Breakage

Aesculap, Inc. is recalling 41 Flexible Bone Awls (SJ607R) because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

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 (foreign body retention) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Aesculap, Inc. is recalling 41 units of the Flexible Bone Awl (model SJ607R, 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 specific product.

The recall is being issued 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 affected products were distributed nationwide in the United States and in Canada. Healthcare facilities and users of these instruments should stop using the recalled Flexible Bone Awls immediately and contact Aesculap, Inc. for instructions on how to return the devices.

The recalled product

Product
Flexible Bone Awl; SJ607R; 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.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
41

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.

See all 4 products in this recall →

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