FDA Medical Device Recalls (openFDA)
Pioneer Surgical Technology: Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
- Recall number
- Z-0021-06
- Recalling firm
- Pioneer Surgical Technology
- Product
- Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
- Status
- Terminated
- Initiated
- 2005-07-29
- Posted
- 2005-10-07
- Terminated
- 2005-10-25
- Reason
- Screw may be incorrectly etched as to length.
- Root cause
- Other
- Action
- Consignees were notified by letter dated 7/29/05 to inspect stocks in storage and at point of use locations hand for correct length and that a firm representative would visit them to pick up any mis-etched product.
- Quantity
- 124
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 308623.
- 510(k) numbers
- ["K041167"]
- PMA numbers
- not on file
- Product code
- NKB
- 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