FDA Medical Device Recalls (openFDA)
Stryker Medical Div. of Stryker Corporation: Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: Service parts are replacement parts for the eye surgery stretcher.
- Recall number
- Z-2343-2010
- Recalling firm
- Stryker Medical Div. of Stryker Corporation
- Product
- Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: Service parts are replacement parts for the eye surgery stretcher.
- Status
- Terminated
- Initiated
- 2010-02-26
- Posted
- 2010-09-01
- Terminated
- 2011-04-21
- Reason
- The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inoperable over time with excessive wear of the brass nut. T
- Root cause
- Device Design
- Action
- The firm, Stryker Medical, sent an "Urgent Medical Device Correction" letter dated February 26, 2010, to all customers. The letter describes the product, problem and action to be taken by customers. The letter states that Stryker field service tech will contact the firm and perform device corrections within four months. The customers were instructed to locate the recalled stretchers and verify that there is no grinding noise when activating the fowler. If the fowler exhibited a grinding noise, the customers were instructed to remove the stretcher from service and contact the recalling firm at 800-STRYKER, option 3. Note: Do not put the stretcher back into service until it is repaired by our field service representative. The customers were also instructed to return the enclosed post card to confirm receipt of this notice; inform any new users and advise the firm of new locations if any of the listed stretchers were on loan or sold, and advise the firm of the obsolescence by providing the serial numbers if any of the listed stretchers were disposed of. If you have any urgent questions or concerns, contact (269) 324-6884. Normal hours are Monday-Friday 8am-5pm(EST).
- Quantity
- 226
- Distribution
- Worldwide distribution: USA and countries including Australia, Canada, Chile, China, France, Germany, Greece, Spain, Italy, Japan, South Africa, Taiwan, Korea, Singapore, and UK.
- Lot, serial or model codes
- There is no code.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNJ
- 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