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Recall

Class II — Zimmer, Inc.

Recalling firmZIMMER, INC.
Registered facilityView this company's 10 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonZimmer Inc. is initiating a removal of the Multipolar® Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
ProductMultipolar® Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar® Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00
Quantity195
DistributionWorldwide Distribution - USA nationwide including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea.
Initiated2012-08-31
Classified2012-11-20
Terminated2013-09-23
Recall numberZ-0410-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Zimmer, Inc. (Z-0410-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63122/

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