CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
Flexible Bone Awl recalled by Aesculap
Aesculap is recalling Flexible Bone Awl, distributed nationwide in the US. The recall was initiated on 10 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0423-2016
- FDA event ID
- 72646
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2015
- FDA classified
- 18 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Nov 2015 | Recall initiated by company | |
| 18 Dec 2015 | Classified by FDA | +38 days |
| 30 Dec 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and country of: Canada.
Questions about this recall
Why was it recalled?
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Which lots are affected?
all lots
Where was it sold?
Worldwide Distribution: US (nationwide) and country of: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 72646This product is part of a recall event; the main page for the event is Flexible Screw Driver SJ706R recalled by Aesculap.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Flexible Screw Driver SJ706R recalled by Aesculap | Aesculap | Device Malfunction | Nationwide | |
| CLASS II | Flexible Drill recalled by Aesculap | Aesculap | Device Malfunction | Nationwide | |
| CLASS II | Tray Set containing multiple instruments recalled by Aesculap | Aesculap | Device Malfunction | Nationwide |
More recalls from Aesculap
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Minop Trocar 4 Wking Channel6 recalled by Aesculap | Aesculap | Device Malfunction | Nationwide |
| Device | CLASS II | Sealing Unit For Trocars recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
| Device | CLASS II | Sealing Cap For Trocars recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
| Device | CLASS II | Reducing Converter recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
| Device | CLASS II | Sealing Unit F/ Trocars W.reducer recalled by Aesculap | Aesculap | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |