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U.S. Department of Health and Human Services

Class 2 Device Recall Barricaid Impactor

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 Class 2 Device Recall Barricaid Impactorsee related information
Date Initiated by FirmJuly 25, 2024
Date PostedAugust 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2688-2024
Recall Event ID 95066
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductBarricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Code Information REF: BAR-IMPACTOR, P/N: 400906-A; UDI-DI: M906IMP1A0; Lot numbers: 10282203, 06152307, 08292301, 10112307.
Recalling Firm/
Manufacturer		 Intrinsic Therapeutics, Inc.
30 Commerce Way
Woburn MA 01801-8503
For Additional Information ContactOscar Yeh
781-932-0222 Ext. 144
Manufacturer Reason
for Recall		At least two units have been found to be missing a weld.
FDA Determined
Cause 2		Process control
ActionOn July 25, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to consignees. Consignee Action Requested: Consignees are requested to take the following steps: 1. Prior to surgery, identify if any Impactors from the affected lots are in your inventory. Prioritize use of Impactors from lots not listed in this Recall letter and ensure that you bring at least two Impactors to the case. 2. Prior to surgery, share the contents of this Recall letter with the surgeon, highlighting the manufacturing defect that has been found and the potential clinical implications. 3. In most cases, there is no need for the Impactor when adhering to the surgical technique manual for Barricaid implantation. While proctoring, remind the surgeon to keep the endplate guide along the surface of the endplate of the vertebral body to be implanted and ensure the distal end of the delivery instrument is against the posterior wall of the vertebra. Confirm proper position before and during malleting by using fluoroscopy. 4. Ensure that If using an Impactor from the affected lot, the surgeon is aware that the tool shaft may be compromised. Use the Impactor per the surgeon technique manual and with fluoroscopic guidance for initial alignment of the instrument and after every 1-2 mallet strikes. If any bending at the weld location is observed, discontinue use of that Impactor and open a second instrument from inventory. 5. If no additional Impactors are available and the Barricaid implant is proud, remove the Implant using a Barricaid Removal Tool. Do not allow the surgeon to attempt to advance the implant further through use of any other instrument as there is a risk of damaging the implant itself. 6. Alternate Impactors will be shipped to you with instructions on returning any Impactors that you may have from the affected lots. Intrinsic will be in touch to provide product return instructions and replace your inventory. 7. Expeditiously fill out the attached acknowledgement form. The completed form c
Quantity in Commerce207 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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.
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