Recall Z-0096-2014
DePuy Spine, Inc. · initiated July 31, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 287105018
Reason for recall
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
FDA-determined cause: Under Investigation by firm
Action taken
DePuy Synthes sent an Urgent Voluntary Product Recall Notification letter dated July 30, 2013, to all affected consignees via Fed Ex overnight delivery. Consignees were informed that DePuy Spine, Inc. is voluntarily recalling all lots of the PIPELINE LS ACCESS SYSTEM Dilators (1 st, 2nd, 3rd, and 4th) and Holding Clip. They were asked to review inventory located at their facility and quarantine any products listed in this recall notice. Consignees were instructed to contact their local DePuy Synthes Spine Sales Consultant to return any inventory located within their facility. Consignees with questions were instructed to call 508-828-3583.
Details
- Recall number
- Z-0096-2014
- Initiated
- July 31, 2013
- Posted by FDA
- October 23, 2013
- Terminated
- June 29, 2015
- Product code
- GCC – Dilator, Catheter
- Quantity
- 100 units
- Distribution
- 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.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0093-2014 Class II | PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-0094-2014 Class II | PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-0095-2014 Class II | PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |
| Z-0097-2014 Class II | PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | 07/31/2013Terminated |