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INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment. Class II

Reason: INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.

Intio Inc 20130226 Terminated
Distributed: Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
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PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework. Class II

Reason: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

Keystone Dental Inc 20130311 Terminated
Distributed: Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
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ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. Class II

Reason: The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.

DePuy Orthopaedics, Inc. 20130225 Terminated
Distributed: Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of Canada, Chile, Germany, Czech Republic, Israel , Norway, Poland, Slovenia, Australia, New Zealand, South Africa, Belgium, Austria, Switzerland, France, England and County Cork, Ireland.
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Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits. Class II

Reason: Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.

DePuy Orthopaedics, Inc. 20130205 Terminated
Distributed: Worldwide Distribution - USA Nationwide.
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CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing. Class II

Reason: The cassettes were shipped with the wrong IP (image plate) size bar code.

AGFA Corp. 20130207 Terminated
Distributed: USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
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Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. Class II

Reason: The recalled product leaks at the connection site.

Molded Products Inc 20120619 Terminated
Distributed: Distributed to one customer in Michigan.
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Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability. Class I

Reason: A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.

Del Mar Reynolds Medical, Ltd. 20130115 Terminated
Distributed: Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
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ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Class II

Reason: The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.

Alphatec Spine, Inc. 20110706 Terminated
Distributed: Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
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20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. Class III

Reason: The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).

Volk Optical Inc 20121025 Terminated
Distributed: Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM. Internationally to Japan.
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Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias. Class II

Reason: An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.

Boston Scientific CRM Corp 20130301 Terminated
Distributed: Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.
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