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Terminated

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

FDA Recall Z-0922-04 · Posted 2004-07-20

Recalling FirmSpinal Concepts, Inc
Recall StatusTerminated
Product CodeKWP
Date Initiated2002-04-01
Date Terminated2004-05-11
Product Quantity108

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.

K983258MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEMSpinal Concepts, Inc. · 1998-10-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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