CLASS II Device recall · Reported 26 Dec 2012 · FDA Enforcement Report
Mayfield Composite Series Skull Clamps recalled by Integra LifeSciences
Integra LifeSciences is recalling Mayfield Composite Series Skull Clamps, distributed nationwide in the US. The recall was initiated on 5 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0559-2013
- FDA event ID
- 63776
- Recalling firm
- Integra LifeSciences, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2012
- FDA classified
- 19 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 5 Nov 2012 | Recall initiated by company | |
| 19 Dec 2012 | Classified by FDA | +44 days |
| 26 Dec 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKentuckyMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraskaNew JerseyNew Mexico
Questions about this recall
Is Mayfield Composite Series Skull Clamps recalled?
Yes. Integra LifeSciences recalled Mayfield Composite Series Skull Clamps on 5 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0559-2013.
Why was it recalled?
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
Which lots are affected?
The recalled product is identified with the Lot Numbers: 096455 and 097546.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
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| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |