FDA Medical Device Recalls (openFDA)
Pioneer Surgical Technology: Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
- Recall number
- Z-0561-04
- Recalling firm
- Pioneer Surgical Technology
- Product
- Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
- Status
- Terminated
- Initiated
- 2004-01-20
- Posted
- 2004-02-27
- Terminated
- 2004-05-20
- Reason
- Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
- Root cause
- Other
- Action
- Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.
- Quantity
- 318
- Distribution
- By Zimmer: Nationwide, Australia, Canada, Germany and United Kingdom.
- Lot, serial or model codes
- Lot 77097300.
- 510(k) numbers
- ["K990804"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1000115331
- Firm city
- Marquette
- 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