Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
Descripción del producto
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''.
Catalog Number 89-0452 (8mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND25 and 33056-NE19; Catalog Number 89-0454 (10mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND26 and 33056-NF02; Catalog Number 89-0030 (FORZA Discectomy Case); UPDATED INFORMATION AS OF 04/12/2012: The firm has revised to amend the affected lot information; lot number 34346-NH30 (PN 89-0545) has been added. At the time of recall initiation 3 units from lot 34346-NH30 were in distribution; all 3 units have since been returned to Orthofix. Recall notice stated all lots are to be returned so all other information remains unchanged.
Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.
USA: AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD,MI, MN, MO, MT, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, RUSSIA, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN,THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
Descripción del producto
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
Worldwide Distribution - USA , Sweden, Germany; France, Portugal, UK, Canada, Australia, and New Zealand,
Descripción del producto
Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill); || Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 || The Triathlon-PKR Knee System is indicated for primary partial knee resurfacing (PKR). This system utilizes two fixation pegs on the femoral component for fixation and alignment. To prepare for these features, a peg drill, drill guide, and drill through femoral trial are provided. The femoral Trial Drill Guide is attached to the Modular Handle and assembled into the holes on the articulation surface of the Femoral Trial. Using the appropriately sized Peg Drill (Small Drill for sizes 1-2, Large Drill for sizes 3-6), both holes are drilled. The Peg drill is advanced until the step on the drill makes contact with the front face of the Femoral Trial Drill Guide.
Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
Descripción del producto
CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. || CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
Descripción del producto
CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. || CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE
Descripción del producto
Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. || The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York
Descripción del producto
StaXx¿ XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) || Catalog number: 11-1525 || The StaXx¿ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx¿ XD System is the CapSure¿ PS Spine System.
Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.
Descripción del producto
02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System || For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.