Stryker Medical Division of Stryker Corporation: Stryker Medical Stretcher Model 1115 Prime Big Wheel 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.

Recall number

Z-2925-2011

Recalling firm

Stryker Medical Division of Stryker Corporation

Product

Stryker Medical Stretcher Model 1115 Prime Big Wheel 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.

Status

Terminated

Initiated

2011-07-19

Posted

2011-08-03

Terminated

2013-08-28

Reason

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

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

91

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.

Lot, serial or model codes

Lots 1104032630, 1104032631, 1104032641, 1104032642, 1104032643, 1104032644, 1104032645, 1104032646, 1104032647, 1104032648, 1104032649, 1104032650, 1104032651, 1104032652, 1104032653, 1104032654, 1104032655, 1104032625, 1104032626, 1104032577, 1104032578, 1104032579, 1104032580, 1104032581, 1104032582, 1104032583, 1104032584, 1104032585, 1104032586, 1104032587, 1104032588, 1104032872, 1104032611, 1104032612, 1104032709, 1104032571, 1104032572, 1104032573, 1104032574, 1104032760, 1104032556, 1104032557, 1104032594, 1104032595, 1104032596, 1104032597, 1104032598, 1104032661, 1104032662, 1104032663, 1104032664, 1104032665, 1104032666, 1104032667, 1104032668, 1104032669, 1104032670, 1104032671, 1104032672, 1104032673, 1104032674, 1104032675, 1104032676, 1104032677, 1104032678, 1104032679, 1104032680, 1104032681, 1104032682, 1104032683, 1104032684, 1104032685, 1104032691, 1104032692, 1104032693, 1104032694, 1104032695, 1104032696, 1104032697, 1104032698, 1104032699, 1104032700, 1104032701, 1104032702, 1104032703, 1104032704, 1104032705, 1104032706, 1104032707 and 1104032708 .

510(k) numbers

not on file

PMA numbers

not on file

Product code

INK

Firm FEI

1831750

Firm city

Portage

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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