FDA Medical Device Recalls (openFDA)
Rultract Inc: Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
- Recall number
- Z-0008-04
- Recalling firm
- Rultract Inc
- Product
- Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
- Status
- Terminated
- Initiated
- 2003-09-18
- Posted
- 2003-10-15
- Terminated
- 2007-03-23
- Reason
- Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
- Root cause
- Other
- Action
- The firm notified their affected consignees by letter on 9/18/2003.
- Quantity
- 2,718 units
- Distribution
- The device was distributed to end-users located nationwide.
- Lot, serial or model codes
- S/Ns: 0001 to 2005, and S/Ns: 2172 to 2885
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWS
- Firm FEI
- 3000717741
- Firm city
- Independence
- Firm state
- OH
- 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