FDA Medical Device Recalls (openFDA)
Stryker Medical Division of Stryker Corporation: 6381 M-1 Cot Fastener, catalog no. 6381000000
- Recall number
- Z-1599-2018
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Product
- 6381 M-1 Cot Fastener, catalog no. 6381000000
- Status
- Terminated
- Initiated
- 2018-03-09
- Posted
- not on file
- Terminated
- 2019-04-09
- Reason
- The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
- Root cause
- Labeling Change Control
- Action
- On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com 3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form. 4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.
- Quantity
- 3
- Distribution
- Product distributed to the Netherlands
- Lot, serial or model codes
- Serial No. 170740538 170740539 170740540
- 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