FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corporation: MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
- Recall number
- Z-1221-04
- Recalling firm
- Integra LifeSciences Corporation
- Product
- MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
- Status
- Terminated
- Initiated
- 2004-06-29
- Posted
- 2004-07-27
- Terminated
- 2004-11-24
- Reason
- Skull pins, which fractured below device specifications during QC testing, were distributed.
- 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
- 69 skull pins were distributed.
- Distribution
- The product was distributed to the following states: NY, TX, MD, CO
- Lot, serial or model codes
- Lot Code: #42358
- 510(k) numbers
- ["K021604"]
- PMA numbers
- not on file
- Product code
- HBL
- Firm FEI
- 3004608878
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28