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U.S. Department of Health and Human Services

Class 2 Device Recall MAYFIELD Infinity XR2 Base UnitExtended

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 Class 2 Device Recall MAYFIELD Infinity XR2 Base UnitExtendedsee related information
Date Initiated by FirmJune 29, 2018
Create DateAugust 01, 2018
Recall Status1 Terminated 3 on February 26, 2020
Recall NumberZ-2593-2018
Recall Event ID 80421
Product Classification Clamp, surgical, general & plastic surgery - Product Code GDJ
ProductMAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E 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.
Code Information 69626; 78445; 81360; 1526205; 1560439; 1610839; 1527910; 1560448; 1621857; 1959100; 2012964
FEI Number 3003418325
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactDr. Patricia Kihn
609-275-0500
Manufacturer Reason
for Recall		There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
FDA Determined
Cause 2		Device Design
ActionThe firm, Integra, sent an "Urgent Voluntary Medical Device Correction Field Safety Notice" dated 6/29/18 to customers. The notification letter instructed customers to perform the following: 1) Review your MAYFIELD XR2 instructions for use. Please pay particular attention to the CAUTIONS listed on page 5 of the accompanying instructions for use section as noted below. " Always make sure the base unit is properly secured to the operating table " The base unit must not be used if the device appears to be damaged or functioning incorrectly " Over-tightening the mechanisms adjustment screws may result in damage to the unit " Over extending or overloading the base unit may result in unintended movement, shortened product life and/or damage to the unit " Do not alter the construction of this device as it may result in serious patient injury " Do not steam sterilize; components may be damaged by high heat leading to device damage and reduced performance 2) Visit Integra website and review video highlighting instructions for use at the following link: https://www.integralife.com/mayfield-imaging-cranial-stabilization-system/category/cranial-stabilization-mayfield-imaging-cranial-stabilization-system 3) Complete and return the attached Field Safety Notice Acknowledgement Form promptly via email: FCA@integralife.com or Fax to: 1-609-750-4220. Distributors were also instructed to: "We also kindly ask you to contact the final customers who may have the affected products and provide them with this letter." On July 20, 2018, an additional Urgent Voluntary Medical Device Recall letter was distributed to customers. The letters ask customers to perform the following: 1. Allow your sales representative to check the current knob assembly on your MAYFIELD Infinity XR2 Radiolucent Base Unit (A2079), Standard; MAYFIELD Infinity XR2 Low Profile Base Unit (A2079A); MAYFIELD Infinity XR2 Radiolucent Base Unit, Extended (A2079E) and MAYFIELD Spine Table Adaptor (
Quantity in Commerce17 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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