Multipolar Bipolar Cup Liner 22 mm LD recallZ-0410-2013 · Zimmer, Inc. · initiated Aug 31, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0410-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 31, 2012
- Posted by the FDA
- Nov 20, 2012
- Recalling firm
- Zimmer, Inc.
- Quantity
- 195
- Product code
- KWY
- FDA submissions
- K833991
- 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 description
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
Code information (models, lots, serial numbers)
Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091.
Other devices under the same FDA submission
23 devices cleared under K833991 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MultiPolar® 5001-47Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- MultiPolar® 5001-50Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- MultiPolar® 5001-50-28Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- MultiPolar® 5001-52Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- MultiPolar® 5001-43Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- MultiPolar® 5001-44Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- MultiPolar® 5001-45Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- MultiPolar® 5001-46Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- MultiPolar® 5001-49Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- MultiPolar® 5001-42-22Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- MultiPolar® 5001-44-28Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- MultiPolar® 5001-50-28Zimmer, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page