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

MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020

FDA Recall Z-1221-04 · Posted 2004-07-27

Recalling FirmIntegra LifeSciences Corporation
Recall StatusTerminated
Product CodeHBL
Date Initiated2004-06-29
Date Terminated2004-11-24
Product Quantity69 skull pins were distributed.

Reason for Recall

Skull pins, which fractured below device specifications during QC testing, were distributed.

Firm Action

The firm notified their customers of the recall via facsimile on 6/29/2004. The faxed notification was followed by a hard copy of the recall letter sent via overnight mail. The letter instructs the customers to immediate cease using of the affected product; complete the Fax Back form provided with the recall notice; and return the affected product to Integra for replacement.

Root Cause

Other

Distribution Pattern

The product was distributed to the following states: NY, TX, MD, CO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021604MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020Ohio Medical Instrument Co., Inc. · 2002-07-29

Official Source

View FDA Recall →

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

↑