Z-0922-04

955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas

Name: Z-0922-04 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas
Creator: Spinal Concepts, Inc
Published: 2002-04-01
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2002-04-01 / Terminated

FDA source

Spinal Concepts, Inc began a recall of 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas on 2002-04-01. The reason FDA records is "The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0922-04
Status: Terminated
Initiated: 2002-04-01
Posted: 2004-07-20
Terminated: 2004-05-11
Recalling firm: Spinal Concepts, Inc.
Product: 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
FDA 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 in commerce: 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
Product codes and lots: All codes

Product code KWP

K983258Class IIModification to Spinal Concepts Bacfix Spinal Fixation SystemSpinal Concepts, Inc. / cleared 1998-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)