—#71982

Product

Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile, Zimmer, Warsaw, IN; Cat. No. 5069-52. The product is used for the injection of bone cement.

FDA product code: JDY — Evacuator, Vapor, Cement Monomer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 60750536.

Why it was recalled

The cartridge is brittle and at increased risk of breakage.

Root cause (FDA determination)

Process change control

Action the firm took

Each consignee is being notified by letter dated June 30, 2008, which will be sent via mail or email. Consignees are requested to return the product. Contact Zimmer at 1-574-372-4487 for assistance.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Australia, Canada, China, Colombia, Germany, India, Japan, Korea, New Zealand, Singapore, Switzerland, Taiwan and Thailand.

Timeline

Recall initiated: 2008-06-30
Posted by FDA: 2008-09-16
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71982. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.