Z-0953-2011

The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system...

Name: Z-0953-2011 The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system...
Creator: Stryker Instruments Division of Stryker Corporation
Published: 2010-10-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-10-04 / Terminated / root cause: packaging

FDA source

Stryker Instruments Division of Stryker Corporation began a recall of The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation... on 2010-10-04. The reason FDA records is "There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection". 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-0953-2011
Status: Terminated
Initiated: 2010-10-04
Posted: 2011-01-25
Terminated: 2011-06-06
Recalling firm: Stryker Corp.
Product: The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
Product code: FQH Lavage, Jet
Reason for recall: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge. For questions regarding this recall call (269) 323-7700.
Quantity in commerce: 103
Distribution: Worldwide Distribution - USA (including all 50 states) and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK.
Product codes and lots: Part Number 0210-210-000; Lot Number 09364012; Expires 12/1/2011

Product code FQH

K972069Class IIStryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips, Rechargeable Battery PackStryker Instruments / cleared 1997-07-29

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)