—#80977

Product

Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K043270
Affected lot / code info: Lot Number 2385866.

Why it was recalled

The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.

Root cause (FDA determination)

Other

Action the firm took

Distributors were initially notified by phone on March 23, 2009. Distributors and user accounts were notified by an "Urgent: Device Recall" letter dated March 31, 2009. The letter described the affected product, reason for recall, risks to health, other information and actions for customers. Customers were instructed to quarantine recalled product and to return it to the Zimmer Distribution Center. For questions about the recall, contact Zimmer, Inc. at 1-800-613-6131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.

Timeline

Recall initiated: 2009-03-23
Posted by FDA: 2009-05-18
Terminated: 2009-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80977. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.