Z-1603-2010

Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San...

Name: Z-1603-2010 Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San...
Creator: Stryker Endoscopy
Published: 2009-07-27
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-07-27 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA on 2009-07-27. The reason FDA records is "Latex-- Certain lots of Product contain undeclared latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1603-2010
Status: Terminated
Initiated: 2009-07-27
Posted: 2010-05-14
Terminated: 2010-12-08
Recalling firm: Stryker Corp.
Product: Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA
Product code: HST Apparatus, Traction, Non-Powered
Reason for recall: Latex-- Certain lots of Product contain undeclared latex.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent: Device Removal notice, dated 7/27/2009 was sent to the sole distributor, Stryker Orthopaedics in New Jersey. The distributor will execute the sub-recall. The firm intends to scrap all returned product at that facility, who will provide a record of disposition. The distributor will notify consignees via a mail packet that will be sent via FedEx overnight mail. Consignees will be instructed to return all product to the distributor, with credit provided per policy.
Quantity in commerce: 842 units
Distribution: Nationwide Distribution
Product codes and lots: lot numbers EN0001, EN0002.

Product code HST

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)