Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TK

FDA device recall Z-2257-2014 · posted 2014-08-17 · Terminated

Recall details

Recalling firm

Ortho Development Corporation

Reason for recall

Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

Action taken

Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.

Root cause

Packaging process control

Status

Terminated

Product code

JWH

Quantity affected

1

Distribution

Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.

Date initiated

2014-07-11

Date posted

2014-08-17

Date terminated

2014-10-06

Location

Draper, UT

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