CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
SMR Shoulder/Spalla Trial Heads ECC . Adaptor recalled
Limacorporate is recalling SMR Shoulder/Spalla Trial Heads ECC . Adaptor, distributed in 16 states. The recall was initiated on 14 Aug 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-2540-2015
- FDA event ID
- 71972
- Recalling firm
- Limacorporate, San Daniele Del Friuli, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2015
- FDA classified
- 2 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 14 Aug 2015 | Recall initiated by company | |
| 2 Sep 2015 | Classified by FDA | +19 days |
| 9 Sep 2015 | 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
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
Where it was distributed
US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia.
AlabamaCaliforniaColoradoFloridaKansasLouisianaMichiganMinnesotaMissouriMontanaNorth CarolinaNevadaNew YorkOhioTexasWashington
Questions about this recall
Why was it recalled?
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Which lots are affected?
Lot Numbers: 14AA146 and 14AA153
Where was it sold?
US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to 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.
Other products in this recall event
1 other product · FDA event 71972| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SMR Shoulder/Spalla Trial Humeral Head diameter recalled | Limacorporate | Potency & Assay | 16 states |
More recalls from Limacorporate
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Prima Eccentrical Adaptor With Screw recalled by Limacorporate S.p.A | Limacorporate | Other | Nationwide |
| Device | CLASS II | Prima Eccentrical Adaptor With Screw recalled by Limacorporate S.p.A | Limacorporate | Other | Nationwide |
| Device | CLASS II | TEMA Elbow - Axle Small recalled by Limacorporate S.p.A | Limacorporate | Other | FL, TX |
| Device | CLASS II | Prima TT Glenoid Monoblock/Modular reverse TT baseplates recalled | Limacorporate | Potency & Assay | 6 states |
| Device | CLASS II | Physica HPS Tibial Liner #6 H10 recalled by Limacorporate S.p.A | Limacorporate | Packaging Defects | 5 states |
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