Z-2594-2018 Class II Terminated
FDA device recall Z-2594-2018 was initiated by Integra LifeSciences Corp. on Jun 29, 2018 and is designated Class II. Reason for recall: There is a potential for the knob assembly in the swivel adapter to fracture/break during use. The recall status is terminated (terminated Feb 26, 2020). Affected quantity: 1 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- Jun 29, 2018
- Termination Date
- Feb 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 units
Product Description
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
Reason for Recall
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV; and to countries of:: Australia, Canada, China, Dominican Republic, Hong Kong, India, Japan, Korea, Malaysia, Mexico, Pakistan, Panama, Peru, Singapore, Sri Lanka, Taiwan, and Thailand.
Code Information
CD-0436
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2594-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026