955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas
- Company
- Spinal Concepts, Inc
- Recall Initiated
- April 1, 2002
- Posted
- July 20, 2004
- Terminated
- May 11, 2004
- Recall Number
- Z-0922-04
- Quantity
- 108
- Firm Location
- Austin, TX
Reason for Recall
The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
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 / Code Info
All codes
Root Cause
Other
Action Taken
The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.
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