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

Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.

FDA Recall Z-0632-2014 · Posted 2014-01-06

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeGFF
Date Initiated2012-06-11
Date Terminated2016-04-18
Product Quantity1 B-Blue-S and 1 B-Green

Reason for Recall

Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

Firm Action

none

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Distribution: Maryland only.

Official Source

View FDA Recall →

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

↑