Z-0559-2013Class II

MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are...

Name: Z-0559-2013 MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are...
Creator: Integra LifeSciences Corporation
Published: 2012-11-05
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2012-11-05 / Terminated

FDA source

Integra LifeSciences Corporation began a recall of MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous... on 2012-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0559-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2012-12-19
Terminated: 2014-02-21
Recalling firm: Integra LifeSciences Corporation
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.
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
Reason for recall: 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
FDA root cause: Under Investigation by firm
Action: Integra issued an 'Urgent: Voluntary Medical Device Recall Notification with 'Recall Acknowledgment and Return Form' to all Integra Sales Representatives and Customers via visit and E-mail on November 5, 2012. The recall notice informs the customers of the firm's receipt of complaints pin-pointing quality issues with the MAYFIELD Base Units and MAYFIELD Skull Clamps which may impair their functionality. The customers are asked to sign and return the enclosed Recall Acknowledgement and Return Form so as to document their receipt of the recall notification and replacement products. The replacement products are to be delivered by the Integra NeuroSpecialist who is also responsible for returning the signed forms to Integra as documentation that the recalled devices have been replaced. Should the customer(s) have questions or concerns, they are directed to contact Integra Customer Service at: 1-877-444-1114,Option 3 for Technical Support.
Quantity in commerce: eight (8) skull clamps were distributed
Distribution: Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
Product codes and lots: The recalled product is identified with the Lot Numbers: 096455 and 097546.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0559-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0558-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19
Z-0559-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code HBL

K120633Class IIMayfield Skull ClampIntegra LifeSciences Corporation / cleared 2012-05-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)