Recall Z-1481-2009
Zimmer Inc. · initiated May 1, 2009
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.
Codes / lots: Lot Number: 61156235.
Reason for recall
The package contains pins with an incorrect diameter.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1481-2009
- Initiated
- May 1, 2009
- Posted by FDA
- June 26, 2009
- Terminated
- November 12, 2009
- Product code
- HTY – Pin, Fixation, Smooth
- Quantity
- 37
- Distribution
- Worldwide Distribution -- US including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan.
- Recalling firm
- Zimmer Inc., Warsaw, IN