FDA Medical Device Recalls (openFDA)
Spinal Concepts, Inc: 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
- Recall number
- Z-0808-04
- Recalling firm
- Spinal Concepts, Inc
- Product
- 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
- Status
- Terminated
- Initiated
- 2004-03-01
- Posted
- 2004-07-20
- Terminated
- 2007-04-13
- Reason
- Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
- Root cause
- Other
- Action
- The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
- Quantity
- 25 (1757-1)
- Distribution
- Nationwide
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K024326"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3000718496
- Firm city
- Austin
- Firm state
- TX
- 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