—#112642

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

FDA product code: KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K833991
Affected lot / code info: Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091.

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-08-31
Posted by FDA: 2012-11-20
Terminated: 2013-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.