Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
FDA device recall Z-0171-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Stryker Instruments, Instruments Div.
- Reason for recall
- Product sterility may have been compromised by an inadequate package seal.
- Action taken
- Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPK
- Quantity affected
- 15
- Distribution
- United States, France and United Kingdom.
- Date initiated
- 2003-11-12
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-03
- Location
- Kalamazoo, MI
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