00-5976-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Arti

FDA device recall Z-1606-2012 · posted 2012-05-14 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are

Action taken

Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514. For questions regarding this recall call 574-372-4807.

Root cause

Labeling design

Status

Terminated

Product code

JWH

Quantity affected

83,322 all sizes

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzer

Date initiated

2012-02-24

Date posted

2012-05-14

Date terminated

2014-04-18

Location

Warsaw, IN

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