DePuy Spine, Inc.: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Agency Publication Date: October 23, 2013

Affected Products

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65897

Status: Resolved

Manufacturer: DePuy Spine, Inc.

Manufactured In: United States

Units Affected: 5 products (118 units; 105 units; 102 units; 100 units; 198 units)

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