Recall Z-2592-2018 ยท GDJ Clamp, Surgical, General & Plastic Surgery
Integra LifeSciences Corp.
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 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.
| Date | Jun 29, 2018 |
| Status | Terminated |
| Reason | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. |
| Root cause | Device Design |
| Action | 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 ma |
| 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 Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.