Recall Z-2594-2018
Integra LifeSciences Corp. · initiated June 29, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: CD-0436
Reason for recall
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
FDA-determined cause: Device Design
Action taken
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 (
Details
- Recall number
- Z-2594-2018
- Initiated
- June 29, 2018
- Terminated
- February 26, 2020
- Product code
- GDJ – Clamp, Surgical, General & Plastic Surgery
- Quantity
- 1 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…
- Recalling firm
- Integra LifeSciences Corp., Plainsboro, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2592-2018 Class II | MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit…There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | 06/29/2018Terminated |
| Z-2593-2018 Class II | MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD Infinity XR2…There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | 06/29/2018Terminated |
| Z-2595-2018 Class II | MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD Infinity XR2…There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | 06/29/2018Terminated |