Mayfield Infinity Xr2 Base Unit recall
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic…
Why was Mayfield Infinity Xr2 Base Unit recalled?
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
57218; 58242; 59524; 61083; 61084; 61533; 61559; 62801; 63826; 63949; 65966; 65967; 66950; 67912; 70432; 70564; 74838; 76382; 78005; 79436; 79475; 81218; 84107; 86162; 88507; 89760; 1468037; 1558488; 1664697; 1755770; 1485531; 1726814; 1737849; 1795116; 1939414; 2051032; 2135345; 2162789; 2247499; 2353536; 2380794; 2450908; 2463223; 2497401; 2517644; 2556854; 2642914; 2642922; 2740222; 2760809; 2760810; 2781235; 2781238
- Product
- MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 409 units
- Distribution
- 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.
- Recall date
- August 8, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)