Recall Z-0410-2013 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Zimmer, Inc.
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
| Date | Nov 20, 2012 (initiated Aug 31, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833991 | BIPOLAR HIP DEVICE Zimmer, Jan 30, 1984 |