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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID 61874
Product Type Devices
Status Ongoing
Recalling Firm DePuy Mitek, Inc., a Johnson & Johnson Co.
City Raynham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles 683 units Z-1937-2012
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles 704 units Z-1938-2012
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles 530 units Z-1939-2012
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. All lots Class II Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles 6979 units Z-1940-2012
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