Recall Z-1481-2009 ยท HTY Pin, Fixation, Smooth
Zimmer Inc.
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.
| Date | Jun 26, 2009 (initiated May 1, 2009) |
| Status | Terminated |
| Reason | The package contains pins with an incorrect diameter. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 37 |
| Distribution | Worldwide Distribution -- US including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.