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

FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)

FDA Recall Z-0895-05 · Posted 2005-06-16

Recalling FirmFHC, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2005-03-14
Date Terminated2008-07-08
Product Quantity169 units

Reason for Recall

Potential for non-sterile pin to contaminate sterile field

Firm Action

FHC notified customers by letter dated 3/14/05 and 3/25/05. The firm has issued a temporary set of instructions which include covering the non-sterile engagement pin with sterile tape and an amended Instruction For Use page to all customers. A redesigned pulley cover which will be sent to all customer when it becomes available in April 2005.

Root Cause

Other

Distribution Pattern

Natiowide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011775MICRO TARGETING DRIVE SYSTEMFHC, Inc. · 2001-08-30K011992FHC MICROTARGETING DRIVE SYSTEMFHC, Inc. · 2001-08-14K003776MICROTARGETING DRIVE SYSTEMFHC, Inc. · 2001-02-23

Official Source

View FDA Recall →

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

↑