Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect De
Summary
The FDA issued a Class II for Driver Instrument, part of the Superion Indirect Decompression System, REF: 102- by Boston Scientific Neuromodulation Corporation. Reason: Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause drive.
Details
Source
Device Recall
External ID
Z-1972-2023
Action Date
2023-06-21
Status
Ongoing
Category
device
Product Description
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Lot/Code Info: Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)
Quantity Affected: 21,533
Reason for Recall
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
Distribution
US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-12
Company
Valencia, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Boston Scientific Neuromodulation Corporation has 11 FDA actions in our database, including 10 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Neuromodulation Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Neuromodulation Corporation have FDA actions?
Boston Scientific Neuromodulation Corporation has 11 FDA actions in our database, including 10 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1972-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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