Stryker Instruments, Instruments Div. Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
Brand
Stryker Instruments, Instruments Div.
Lot Codes / Batch Numbers
Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.
Products Sold
Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.
Stryker Instruments, Instruments Div. is recalling Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000. due to Product sterility may have been compromised by an inadequate package seal.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product sterility may have been compromised by an inadequate package seal.
Recommended Action
Per FDA guidance
Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026