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Terminated

PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

FDA Recall Z-1712-2014 · Posted 2014-06-04

Recall StatusTerminated
Product CodeLXH
Date Initiated2014-04-30
Date Terminated2014-12-01
Product Quantity140 units

Reason for Recall

Difficulty removing the cup adaptor from the impaction handle during surgery

Firm Action

Firm has initiated the recall by email on 04/28/2014 to all distributor's offices, including international, then followed with written communication on 05/02/2014 via Fed Ex P1 delivery to all United States consignees. Follow-up to non-responding consignees will commence 30 days after initiation.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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