FDA Medical Device Recalls (openFDA)
Pioneer Surgical Technology: StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer
- Recall number
- Z-0948-03
- Recalling firm
- Pioneer Surgical Technology
- Product
- StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer
- Status
- Terminated
- Initiated
- 2003-05-28
- Posted
- 2003-06-21
- Terminated
- 2003-09-12
- Reason
- Label may bear an incorrect part number [2227-02-02] and size [03.8MM].
- Root cause
- Other
- Action
- A recall letter dated 5/28/03 was sent to the sole distributor, asking them to recall from their customers.
- Quantity
- 159
- Distribution
- Indiana
- Lot, serial or model codes
- lot 77091367.
- 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