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Terminated

SMR allen wrench 5 mm, product code 9013.50.210

FDA Recall Z-2707-2016 · Posted 2016-08-31

Recalling FirmLimacorporate S.p.A
Recall StatusTerminated
Product CodeLXH
Date Initiated2016-07-21
Date Terminated2017-01-13
Product Quantity76

Reason for Recall

Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.

Firm Action

The firm received two complaints from the US field about the inta-operative malfunction with the SMR allen wrench 5mm (product code 9013.50.210) with the T-handle. Both parts involved were manufactured with the same lot #14AA311. No adverse effects for patients reported.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US, Italy, Australia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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