—#112870

Product

CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K960658
Affected lot / code info: Item 00-8114-001-10, lots 61947699 and 61952551

Why it was recalled

Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.

Root cause (FDA determination)

Packaging change control

Action the firm took

Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.

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 Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.

Timeline

Recall initiated: 2012-09-13
Posted by FDA: 2012-10-15
Terminated: 2014-01-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112870. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.