SMR glenosphere impactor/extractor — Class II medical device recall Z-1711-2016
Terminated recall by Limacorporate S.p.A, reported 2016-06-01, distributed nationwide. Complaints of intra-operative breakage of the glenosphere impactors/extractors.
| Recall number | Z-1711-2016 |
|---|---|
| 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 | 2016-04-08 |
| Classified | 2016-05-24 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2016-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 314 units |
| Reason classes | device malfunction |
| Lot numbers | 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600 |
Product
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Reason for recall
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
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-1711-2016. 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.