Z-2924-2011

Stryker Medical Stretcher Model 1089 Eye Surgery A wheeled stretcher consists of a platform mounted on a...

Name: Z-2924-2011 Stryker Medical Stretcher Model 1089 Eye Surgery A wheeled stretcher consists of a platform mounted on a...
Creator: Stryker Medical Division of Stryker Corporation
Published: 2011-07-19
License: https://open.fda.gov/license/

Stryker Medical / initiated 2011-07-19 / Terminated / root cause: manufacturing process

FDA source

Stryker Medical Division of Stryker Corporation began a recall of Stryker Medical Stretcher Model 1089 Eye Surgery A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients... on 2011-07-19. The reason FDA records is "Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may...". 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-2924-2011
Status: Terminated
Initiated: 2011-07-19
Posted: 2011-08-03
Terminated: 2013-08-28
Recalling firm: Stryker Medical
Product: Stryker Medical Stretcher Model 1089 Eye Surgery A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.
Product code: INK Stretcher, Wheeled, Powered
Reason for recall: Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Medical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 18, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected stretchers and to test the brakes. If the brakes are found to be inoperable, customers are instructed to remove the stretchers from service and contact the firm at 800-STRYKER, option 3. Additionally, customers are instructed not to put the stretchers back in service until they are repaired by the firm's field service representative. For units with properly functioning brakes, the letter also instructs the user to test the brakes before each use until the unit has been serviced. A post card was enclosed to confirm receipt of the letter. Questions or concerns may be addressed by calling Stryker at 269-389-6604.
Quantity in commerce: 4
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, CA, FL, GA, HI, IL, MA, MN, MO, NH, NJ, NV, NY, PA, RI, TX, UT, and VA and the country of THE NETHERLANDS.
Product codes and lots: Lots 1104030116, 1104030117, 1104030029 and 1104030077.

Product code INK

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)