Integra LifeSciences Corporation

Reference number A-2079, Serial number(s) XB091031, XB091032, XB091033, XB091034, XB091035, XB091036, XB091037, XB091038, XB091039, XB091040, XB091041, XB091042, XB091043, XB091044, XB091045, XB091046, XB091047, XB091048, XB091049, XB091050

General and Plastic Surgery Devices

1

No

Product was shipped to the following states: IN, MO, NJ, TX and VA. Product was also sold in Belgium, Canada and New Zealand.

Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory 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.

Catalog number 519110, Kit S/N: PAN-001, PANTAXL-015; PAN-003, PANTAXL-017; PAN-004, PANTAXL-019; PAN-006, PANTAXL-020; PAN-013, PANTAXL-022; PAN-016, PANTAXL-026; PAN-018, PANTAXL-029; PAN-021, PANTAXL-031; PAN-023, PANTAXL-032; PAN-024, PANTAXL-033; PAN-025, PANTAXL-034; PAN-027, PANTAXL-035; PAN-030, PANTAXL-036; PAN-038, PANTAXL-039; PANTAXL-008, PANTAXL-040; PANTAXL-011, PANTAXL-042 & PANTAXL-012

Orthopedic Devices

2

Yes

Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA and WI; and countries of: Australia, Austria, Belgium, Czech Republica, Denmark, Finland, France, Germany, Ireland, Italy, Portugal, South Africa, Spain, Switzerland, and United Kingdom.

Panta Support Device Panta¿ Arthrodesis Nail Instrumentation Tray One unit per package. || The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.

Part Number: 111434SND  Lot Number: E6DO

Orthopedic Devices

2

Yes

Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.

Qwix 4.3mm Stabilization Screws - 34mm

Part Number: 111432SND  Lot Number: E6CZ

Orthopedic Devices

2

Yes

Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.

Qwix 4.3mm Stabilization Screws - 32mm

The recalled product is identified with the Lot Numbers: 096455 and 097546.

Neurological Devices

2

No

Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.

MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. || The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.