The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0422-2016·Announced 2015-12-30

Aesculap Flexible Screw Driver Recalled Due to Potential Shaft Breakage

Aesculap, Inc. is recalling 37 Flexible Screw Driver SJ706R units because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 fragments remaining in a patient during surgery, which aligns with the rubric criteria for significant injury risk.

Plain-English summary

Aesculap, Inc. is recalling 37 units of the Flexible Screw Driver SJ706R (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 and includes distribution in the United States (nationwide) and Canada.

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.

Healthcare facilities and consumers who have these products should stop using them immediately and contact Aesculap, Inc. for instructions on return or replacement.

The recalled product

Product
Flexible Screw Driver SJ706R; 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 Instrument
Hazard
Affected units
37

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 →

Related recalls

Same manufacturer · Aesculap, Inc.

See all →

Same hazard · foreign body

See all →

Similar recalls