Recall Z-0120-04 ยท JDW Pin, Fixation, Threaded
Zimmer Inc
Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/2 inches in length. Catalog # 281-01-05.
| Date | Jul 20, 2004 (initiated Oct 15, 2003) |
| Status | Terminated |
| Reason | The pin may fail because the metal used to make the pin does not meet the firm's hardness specification. |
| Root cause | Other |
| Action | All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients. |
| Distribution | The majority of the pins were distributed within the United States. Distribution also occured in seven foreign countries; Taiwan, Canada, Japan, Korea, Belgium, Australia and Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.