FDA Medical Device Recalls (openFDA)
Stryker Medical Division of Stryker Corporation: Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
- Recall number
- Z-2207-2021
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Product
- Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
- Status
- Open, Classified
- Initiated
- 2021-05-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
- Root cause
- Under Investigation by firm
- Action
- Stryker notified users/consumers via written notification Urgent Medical Device Removal letter notified via FedEx on Friday, June 18, 2021. In addition, customers may be contacted by phone or email. International distribution divisions were notified by validated electronic system (Trackwise) on May 13, 2021. Letter states reason for recall, health risk and action to take: Customers are instructed to: 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax (269) 488-8691or email productfieldaction@stryker.com to Stryker's Regulatory Department. 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers Regulatory Department. 4. Upon receipt of the signed business reply form, Stryker will contact you to arrange the removal of your product(s) if applicable. If you have any questions or concerns, contact us at +1 269 389 8306 or productfieldaction@stryker.com. We apologize for any disruption this may cause.
- Quantity
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
- Lot, serial or model codes
- UDI (DI#) 07613327278149 07613327278149 07613327278194
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPO
- Firm FEI
- 1831750
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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