Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2540-2015 — 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.

U.S. FDA — Device Enforcement · Italy · 2015-08-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2540-2015
Date of alert
2015-08-14
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Limacorporate S.p.A
Product category
device
Product type
Devices
Reported risk: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.