Recall Z-0171-04 ยท FPK Tubing, Fluid Delivery
Stryker Instruments, Instruments Div.
Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
| Date | Jul 20, 2004 (initiated Nov 12, 2003) |
| Status | Terminated |
| Reason | Product sterility may have been compromised by an inadequate package seal. |
| Root cause | Other |
| Action | Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product. |
| Quantity | 15 |
| Distribution | United States, France and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.