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

AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

FDA Recall Z-0829-2014 · Posted 2014-01-27

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBC
Date Initiated2011-03-31
Date Terminated2019-07-18
Product Quantity599 cutting burs

Reason for Recall

Cutter was longer than was stated on the label

Firm Action

Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887. For questions regarding this recall, call 800-327-6887.

Root Cause

Pending

Distribution Pattern

Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011444ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc. · 2001-08-08K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc. · 1998-07-06

Official Source

View FDA Recall →

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

↑