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U.S. Department of Health and Human Services

Class 2 Device Recall Superion Indirect Decompression System (IDS)

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  Class 2 Device Recall Superion Indirect Decompression System (IDS) see related information
Date Initiated by Firm October 12, 2022
Date Posted November 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0230-2023
Recall Event ID 90915
PMA Number P140004 
Product Classification Prosthesis, spinous process spacer/plate - Product Code NQO
Product Superion¿ Indirect Decompression System (IDS)

Model Numbers and Size:
101-9808 - 8mm
01-9812 - 12mm
101-9814 - 14mm
Code Information Model (UPN): 101-9808 UDI-DI (GTIN) Code: 00884662000529 Lot/Batch Numbers: 26176977 Model (UPN): 101-9812 UDI-DI (GTIN) Code: 00884662000543 Lot/Batch Numbers: 26573432 26375758 26815560 26807662 26654632 26928168 26929605 26489700 Model (UPN): 101-9814 UDI-DI (GTIN) Code: 00884662000550 Lot/Batch Numbers: 26366842 26848047 26619510 26323984 26406210 26799951
Recalling Firm/
Manufacturer		 Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information Contact Jessica Sachariason
415-730-2310
Manufacturer Reason
for Recall		 Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.
FDA Determined
Cause 2		 Process change control
Action On 10/12/2022, the firm, Boston Scientific, sent an "Urgent: Medical Device Recall" letter via FedEx to customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: -Review their facility's device inventory: Segregate and return any unused Superion IDS devices from the affected subset to Boston Scientific. Complete and return account-specific Reply Verification Tracking Form via Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center at 1-763-415-7708. -Patient follow-up: Discuss this advisory with their patient(s) who are implanted with an affected device. Promptly investigate any reported pain and/or discomfort, or any suspected indication of migration of the Superion IDS implant, which may suggest a potential spindle cap weld break. If an affected device remains implanted in their patient, and successful deployment and/or device structural integrity is questioned, consider confirming via imaging. -If a spindle cap weld break is confirmed post-implant: Assess the clinical benefits versus risks associated with explanting an affected Superion IDS from their patient. Note that the Superion IDS Inserter tool would be unable to engage a non-intact device for explant. Medical judgement is required for determining the appropriate surgical method for explant in such cases. -Records: For each patient with an affected Superion IDS, append their medical record with a copy of this letter to maintain awareness of this topic for the remaining service life of the device. Should any revision/replacement occur, please inform Boston Scientific with relevant clinical information. For additional information or questions - contact the local Boston Scientific representative, or the Firm's Public Contact, Director, Global Corporate Communications at 415-730-2310 or jessica.sachariason@bsci.com.
Quantity in Commerce 175 devices
Distribution U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NQO and Original Applicant = Boston Scientific Neuromodulation
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