—#81881

Product

Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer, Warsaw, IN; Model Number: 00-0187-03-69. Steinmann Pins are utilized in skeletal traction for alignment and reduction of long bone fractures as guide wires in hip pinning and for fracture alignment in certain other types of fractures.

FDA product code: HTY — Pin, Fixation, Smooth
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot Number: 61156235.

Why it was recalled

The package contains pins with an incorrect diameter.

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer, Inc. issued an "Urgent: Device Recall" letter informing users of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, 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 including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan.

Timeline

Recall initiated: 2009-05-01
Posted by FDA: 2009-06-26
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.