955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas
FDA Recall Z-0921-04 · Posted 2004-07-20
Advertisement
Recalling FirmSpinal Concepts, Inc
Recall StatusTerminated
Product CodeKWP
Date Initiated2002-04-01
Date Terminated2004-05-11
Product Quantity183
Reason for Recall
The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
Firm Action
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
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement