Integra LifeSciences Corporation MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
Brand
Integra LifeSciences Corporation
Lot Codes / Batch Numbers
Lot Code: #42358
Products Sold
Lot Code: #42358
Integra LifeSciences Corporation is recalling MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 due to Skull pins, which fractured below device specifications during QC testing, were distributed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Skull pins, which fractured below device specifications during QC testing, were distributed.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, MD, NY, TX
Page updated: Jan 10, 2026