CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
Acufex Trunav Retrograde Drill Product Number recalled by Smith & Nephew
Smith & Nephew is recalling Acufex Trunav Retrograde Drill Product Number: 72204042 The Acufex Trunav Retrograde, distributed nationwide in the US. The recall was initiated on 15 Mar 2017 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-1843-2017
- FDA event ID
- 76824
- Recalling firm
- Smith & Nephew, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2017
- FDA classified
- 18 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Mar 2017 | Recall initiated by company | |
| 18 Apr 2017 | Classified by FDA | +34 days |
| 26 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Product as listed by the FDA
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Where it was distributed
Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
Questions about this recall
Why was it recalled?
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Which lots are affected?
Batch Numbers: F92143, F92147, G10380, G10382, G11216, G11217 G11231, G11232, G15940, G15943, G18835, G18836, G30219 G30220, G30254, G30255, G32180, G32182, G32183, G32184
Where was it sold?
Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
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
13 other products · FDA event 76824This product is part of a recall event; the main page for the event is Acufex Trunav Retrograde Drill Product Number recalled by Smith & Nephew.
More recalls from Smith & Nephew
All 258| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew | Smith & Nephew | Other | DE |
| Device | CLASS II | Biosure HA Screw Threaded metallic bone fixation fastener recalled | Smith & Nephew | Labeling Errors | Nationwide |
| Device | CLASS II | Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew | Smith & Nephew | Other | Nationwide |
| Device | CLASS II | Bioraptor Suture Anchors recalled by Smith & Nephew | Smith & Nephew | Sterility | Nationwide |
| Device | CLASS II | Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew | Smith & Nephew | Other | TN |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |