955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas
FDA device recall Z-0920-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Spinal Concepts, Inc
- Reason for recall
- The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
- Action taken
- The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 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 fol
- Date initiated
- 2002-04-01
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-11
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BACFIX SPINAL FIXATION SYSTEM (K964404) | Spinal Concepts, Inc. | 1997-03-26 |