Atlas FDA

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

FDA device recall Z-1712-2014 · posted 2014-06-04 · Terminated

Recall details

Recalling firm
Microport Orthopedics INC.
Reason for recall
Difficulty removing the cup adaptor from the impaction handle during surgery
Action taken
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
Status
Terminated
Product code
LXH
Quantity affected
140 units
Distribution
Nationwide Distribution.
Date initiated
2014-04-30
Date posted
2014-06-04
Date terminated
2014-12-01
Location
Arlington, TN

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