CLASS II Device recall · Reported 1 Jun 2016 · FDA Enforcement Report
SMR glenosphere impactor/extractor recalled by Limacorporate S.p.A
Limacorporate S.p.A is recalling SMR glenosphere impactor/extractor, distributed nationwide in the US. The recall was initiated on 8 Apr 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-1711-2016
- FDA event ID
- 73870
- Recalling firm
- Limacorporate S.p.A, San Daniele Del Friuli, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2016
- FDA classified
- 24 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2016 | Recall initiated by company | |
| 24 May 2016 | Classified by FDA | +46 days |
| 1 Jun 2016 | 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
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
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
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Where it was distributed
Distributed US (nationwide) and in Australia.
Questions about this recall
Is SMR glenosphere impactor/extractor recalled?
Yes. Limacorporate S.p.A recalled SMR glenosphere impactor/extractor on 8 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1711-2016.
Why was it recalled?
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Which lots are affected?
Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600
Where was it sold?
Distributed US (nationwide) and in 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 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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|---|---|---|---|---|---|
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