Recall record at a glance
| Official record | Z-0095-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | DePuy Spine, Inc. |
| Report date | Nov 6, 2013 |
| Recall initiation date | Jul 31, 2013 |
| Quantity | 102 units |
| Location | Raynham, MA, United States |
Official product description
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.
Why the product was recalled
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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