FDA Medical Device Recalls (openFDA)
Spinal Concepts, Inc: SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas
- Recall number
- Z-0880-05
- Recalling firm
- Spinal Concepts, Inc
- Product
- SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas
- Status
- Terminated
- Initiated
- 2002-07-01
- Posted
- 2005-06-11
- Terminated
- 2005-12-20
- Reason
- Complaints were recieved where swivels came out of plate and where the screw went through the plate.
- Root cause
- Other
- Action
- The firm initiated the recall via telephone communication from sales representatives around August 2002.
- Quantity
- 10 systems
- Distribution
- Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA
- Lot, serial or model codes
- All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254
- 510(k) numbers
- ["K013979"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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