NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen system is a semiconstrained, nonlinked c

FDA device recall Z-0437-2013 · posted 2012-11-26 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer is initiating a lot specific recall of the NexGen Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset

Action taken

Zimmer sent an Urgent Medical Device Recall letter dated September 21, 2012, to all affected customers. The letter identifiedthe product, the problem, and the action to be taken by the customer. Customers were instructed to locate and quarantine the affected product. Customers were to return the affected product along with the completed Inventory Return Certificate Form. If product was further distributed the Recall Letter should be forwarded to their customers. Product was to be returned to USA accounts - Zimmer Product Service Department, 1777 West Center St. Warsaw, IN 46580. If product has been implanted, affected surgeons will be notified. For questions regarding this recall call 574-372-4807.

Root cause

Process change control

Status

Terminated

Product code

JWH

Quantity affected

123 worldwide (33 USA)

Distribution

Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,

Date initiated

2012-09-21

Date posted

2012-11-26

Date terminated

2014-04-17

Location

Warsaw, IN

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