—#165397

Product

MAYFIELD 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.

FDA product code: GDJ — Clamp, Surgical, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 69626; 78445; 81360; 1526205; 1560439; 1610839; 1527910; 1560448; 1621857; 1959100; 2012964

Why it was recalled

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Root cause (FDA determination)

Device Design

Action the firm took

The 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 (

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

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.

Timeline

Recall initiated: 2018-06-29
Terminated: 2020-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.