MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R 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.
Reported: August 8, 2018 Initiated: June 29, 2018 #Z-2595-2018
Product Description
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R 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.
Reason for Recall
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 95 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.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R 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.. Recalled by Integra LifeSciences Corp.. Units affected: 95 units.
Why was this product recalled? ▼
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2595-2018.
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