Z-0410-2013Class II

Multipolar Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22

Name: Z-0410-2013 Multipolar Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22
Creator: Zimmer, Inc.
Published: 2012-08-31
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-08-31 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Multipolar 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... on 2012-08-31. FDA classified it as Class II and gives the reason as "Zimmer 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0410-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-31
Posted: 2012-11-20
Terminated: 2013-09-23
Recalling firm: Zimmer GmbH
Product: Multipolar 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
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: Zimmer 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Zimmer sent an Urgent Medical Device Recall letter to all affected consignees during the week of September 3, 2012. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, quarantine the recalled product and return remaining inventory. Customers were advised to complete Inventory Return Certification form attached.
Quantity in commerce: 195
Distribution: Worldwide 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.
Product codes and lots: Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0410-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0410-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code KWY

K833991Class IIBipolar Hip DeviceZimmer / cleared 1984-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)