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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 65897
Product Type Devices
Status Ongoing
Recalling Firm DePuy Spine, Inc.
City Raynham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-31
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105005 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. 118 units Z-0093-2014
PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105010 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. 105 units Z-0094-2014
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105014 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. 102 units Z-0095-2014
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105018 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. 100 units Z-0096-2014
PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105090 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. 198 units Z-0097-2014
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