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 Smith & Nephew Acufex Trunav Retrograde Drill Product Number: 72204050 The Acufex Trunav, 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-1851-2017
- 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 12MM Product Number: 72204050 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
Is Acufex Trunav Retrograde Drill Product Number: 72204050 The Acufex Trunav Retrograde recalled?
Yes. Smith & Nephew recalled Acufex Trunav Retrograde Drill Product Number: 72204050 The Acufex Trunav Retrograde on 15 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1851-2017.
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: G11228, G18821
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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