FDA Device recall Z-0559-2013
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633 by Integra Lifesciences, citing an investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0559-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-05 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
Reason
An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d
Identifiers
| code_info | The recalled product is identified with the Lot Numbers: 096455 and 097546. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0559-2013%22
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