Z-2864-2011

Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a horizontal position

Name: Z-2864-2011 Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a horizontal position
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 Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a horizontal position on 2011-07-19. The reason FDA records is "The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have...". 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-2864-2011
Status: Terminated
Initiated: 2011-07-19
Posted: 2011-07-22
Terminated: 2013-08-29
Recalling firm: Stryker Medical
Product: Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a horizontal position.
Product code: FPO Stretcher, Wheeled
Reason for recall: The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included. For additional information call (269) 389-6604.
Quantity in commerce: 5
Distribution: Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.
Product codes and lots: Model: 1089 Lots: 1102034587, 1102034588, 1102034589, 1102034590, and 1102034591.

Product code FPO

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)