Recall Z-0920-04 ยท KWP Appliance, Fixation, Spinal Interlaminal
Spinal Concepts, Inc
955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas
| Date | Jul 20, 2004 (initiated Apr 1, 2002) |
| Status | Terminated |
| 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 | 145 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964404 | BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc., Mar 26, 1997 |