Recalls / —

—#112643

Product

CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Affected lot / code info

Lot 61947708

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 #112643. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.