Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

FDA Recall Z-1377-2013 · Posted 2013-05-24

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBE
Date Initiated2011-03-04
Date Terminated2013-12-17
Product Quantity1,827 burrs

Reason for Recall

Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Firm Action

Anspach sent an URGENT: Medical Device Correction letter dated March 4, 2011 to its customers identifying the affected product and actions to be taken by the customers. Customers questions or concerns should be directed to Anspach Customer Support at (800) 327-6887.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113476ANSPACH DISSECTION TOOLSThe Anspach Effort, Inc. · 2011-12-16

Official Source

View FDA Recall →

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

↑