510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1712-2014Class II

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

Microport Orthopedics Inc. / initiated 2014-04-30 / Terminated / root cause: design

Microport Orthopedics INC. began a recall of PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument on . FDA classified it as Class II and gives the reason as "Difficulty removing the cup adaptor from the impaction handle during surgery". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1712-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Microport Orthopedics Inc.
Product
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Product code
LXH Orthopedic Manual Surgical Instrument
Reason for recall
Difficulty removing the cup adaptor from the impaction handle during surgery
Root cause tag
design
FDA root cause
Device Design
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.
Quantity in commerce
140 units
Distribution
Nationwide Distribution.
Product codes and lots
Lot Number(s): 1153896, 1279714, 1288604, and 1314793

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1712-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1712-2014Class IITerminatedVoluntary: Firm initiated