Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PG

FDA device recall Z-0184-2013 · posted 2012-10-31 · Terminated

Recall details

Recalling firm

Wright Medical Technology Inc

Reason for recall

There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

Action taken

Wright sent an Urgent Product Recall Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and immediately return to Wright Medical Technology, Inc. Customers were asked to complete and return the enclosed notification form by fax to 901-867-7401. For questions customers should call 901-867-4324. For questions regarding this recall call 901-867-4655.

Root cause

Packaging process control

Status

Terminated

Product code

LPH

Quantity affected

729 units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway

Date initiated

2012-09-05

Date posted

2012-10-31

Date terminated

2014-01-07

Location

Arlington, TN

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