FDA Medical Device Recalls (openFDA)
Spinal Concepts, Inc: 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas
- Recall number
- Z-0922-04
- Recalling firm
- Spinal Concepts, Inc
- Product
- 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas
- Status
- Terminated
- Initiated
- 2002-04-01
- Posted
- 2004-07-20
- Terminated
- 2004-05-11
- Reason
- The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
- Root cause
- Other
- Action
- The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.
- Quantity
- 108
- Distribution
- Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy
- Lot, serial or model codes
- All codes
- 510(k) numbers
- ["K983258"]
- PMA numbers
- not on file
- Product code
- KWP
- 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