SMR Shoulder/Spalla Trial Humeral Head diameter — Class II medical device recall Z-2539-2015
Terminated recall by Limacorporate S.p.A, reported 2015-09-09, distributed in AL, CA, CO, FL, KS, LA, MI, MN…. The dimensions of the mating features of the recalled products are out of specification causing the device to
| Recall number | Z-2539-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Limacorporate S.p.A, San Daniele Del Friuli, N/A, Italy |
| Recall initiated | 2015-08-14 |
| Classified | 2015-09-02 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-02-26 |
| Distributed | AL, CA, CO, FL, KS, LA, MI, MN, MO, MT, NC, NV, NY, OH, TX, WA |
| Countries outside the US | AU |
| Quantity | 110 units |
| Reason classes | specification failure |
| Lot numbers | 14AA233, 14AA234, 14AA235 |
| Model numbers | 9013.22.425, 9013.22.445, 9013.22.465 |
Product
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2539-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.