Z-1221-04

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

Name: Z-1221-04 MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
Creator: Integra LifeSciences Corporation
Published: 2004-06-29
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2004-06-29 / Terminated

FDA source

Integra LifeSciences Corporation began a recall of MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 on 2004-06-29. The reason FDA records is "Skull pins, which fractured below device specifications during QC testing, were distributed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1221-04
Status: Terminated
Initiated: 2004-06-29
Posted: 2004-07-27
Terminated: 2004-11-24
Recalling firm: Integra LifeSciences Corporation
Product: MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
Reason for recall: Skull pins, which fractured below device specifications during QC testing, were distributed.
FDA root cause: Other
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.
Quantity in commerce: 69 skull pins were distributed.
Distribution: The product was distributed to the following states: NY, TX, MD, CO
Product codes and lots: Lot Code: #42358

Product code HBL

K021604Class IIMayfield Radiolucent Skull Pins, Model 4-0-a-2020Ohio Medical Instrument Co., Inc. / cleared 2002-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)