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Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Class II

Reason: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.

Synthes USA HQ, Inc. 20120907 Terminated
Distributed: Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
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Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments. Class II

Reason: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

Synthes USA HQ, Inc. 20131003 Terminated
Distributed: Nationwide Distribution
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Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant. Class II

Reason: One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.

Synthes USA HQ, Inc. 20131015 Terminated
Distributed: Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.
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Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags. Class II

Reason: Incomplete foil seal on one lot of sterile product.

Baxter Healthcare Corp. 20130925 Terminated
Distributed: Nationwide Distribution including WV, KY, IA, AR, OH, IL, IN, MI, KS, TN, WI, MN, MO.
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Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation. Class II

Reason: A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.

Synthes USA HQ, Inc. 20130622 Terminated
Distributed: Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
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3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions. Class II

Reason: All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.

Synthes USA HQ, Inc. 20130722 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and internationally to Canada.
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Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. Class II

Reason: Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.

Mindray DS USA, Inc. dba Mindray North America 20131007 Terminated
Distributed: Worldwide Distribution - USA Nationwide
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Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients. Class II

Reason: All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.

Synthes USA HQ, Inc. 20130731 Terminated
Distributed: Nationwide Distribution.
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Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of. Class II

Reason: The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

Synthes USA HQ, Inc. 20130731 Terminated
Distributed: US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.
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Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine. Class III

Reason: Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.

Lin-Zhi International Inc 20131003 Terminated
Distributed: US Distribution in CA.
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