CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
SMR allen wrench, product recalled by Limacorporate S.p.A
Limacorporate is recalling SMR allen wrench. The recall was initiated on 21 Jul 2016 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-2707-2016
- FDA event ID
- 74827
- Recalling firm
- Limacorporate, San Daniele Del Friuli, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jul 2016
- FDA classified
- 31 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Jul 2016 | Recall initiated by company | |
| 31 Aug 2016 | Classified by FDA | +41 days |
| 7 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.
Product as listed by the FDA
SMR allen wrench 5 mm, product code 9013.50.210
Where it was distributed
US, Italy, Australia
Questions about this recall
Why was it recalled?
Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.
Which lots are affected?
14AA311
Where was it sold?
US, Italy, Australia
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.
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