Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm recall — FDA Z-2931-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
28,065medical device recall records
2,353FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 923
28,065 detailed records are currently available in this category.
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Extension Block recall — FDA Z-2987-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Set Screw recall — FDA Z-2897-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 50mm Straight Rod recall — FDA Z-2950-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 35mm MIS rod recall — FDA Z-2883-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm recall — FDA Z-2938-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 500mm Straight Rod recall — FDA Z-2960-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
International Medsurg Connection Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8 recall — FDA Z-2825-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 70mm Straight Rod recall — FDA Z-2952-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
International Medsurg Connection Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 recall — FDA Z-2814-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 120mm MIS Rod recall — FDA Z-2896-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Rod Bender recall — FDA Z-2995-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
International Medsurg Connection Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0 recall — FDA Z-2844-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 16, 2017
International Medsurg Connection Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0 recall — FDA Z-2828-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Compass recall — FDA Z-2991-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 45mm MIS Rod recall — FDA Z-2892-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Head Holder recall — FDA Z-3007-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
International Medsurg Connection Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 recall — FDA Z-2817-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 50mm MIS Rod recall — FDA Z-2893-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver recall — FDA Z-2966-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Large Crosslink recall — FDA Z-2878-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
International Medsurg Connection Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case recall — FDA Z-2854-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 16, 2017
International Medsurg Connection Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0 recall — FDA Z-2840-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 16, 2017
International Medsurg Connection Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5 recall — FDA Z-2834-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.