Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
This recall is currently active, issued August 20, 2024. It was issued by Intrinsic Therapeutics, Inc..
- Company
- Intrinsic Therapeutics, Inc.
- Recall Initiated
- July 25, 2024
- Posted
- August 20, 2024
- Recall Number
- Z-2688-2024
- Quantity
- 207 units
- Firm Location
- Woburn, MA
- Official Source
- View on FDA website ↗
Reason for Recall
At least two units have been found to be missing a weld.
Distribution
US Nationwide distribution.
Lot / Code Info
REF: BAR-IMPACTOR, P/N: 400906-A; UDI-DI: M906IMP1A0; Lot numbers: 10282203, 06152307, 08292301, 10112307.
Root Cause
Process control
Action Taken
On 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