Z-0171-04

Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000

Name: Z-0171-04 Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000
Creator: Stryker Instruments, Instruments Div.
Published: 2003-11-12
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2003-11-12 / Terminated / root cause: packaging

FDA source

Stryker Instruments, Instruments Div. began a recall of Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000 on 2003-11-12. The reason FDA records is "Product sterility may have been compromised by an inadequate package seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0171-04
Status: Terminated
Initiated: 2003-11-12
Posted: 2004-07-20
Terminated: 2004-05-03
Recalling firm: Stryker Corp.
Product: Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
Product code: FPK Tubing, Fluid Delivery
Reason for recall: Product sterility may have been compromised by an inadequate package seal.
Root cause tag: packaging
FDA 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 in commerce: 15
Distribution: United States, France and United Kingdom.
Product codes and lots: Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.

Product code FPK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)