Intrinsic Therapeutics, Inc.: Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

Recall number

Z-2688-2024

Recalling firm

Intrinsic Therapeutics, Inc.

Product

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

Status

Open, Classified

Initiated

2024-07-25

Posted

2024-08-20

Terminated

not on file

Reason

At least two units have been found to be missing a weld.

Root cause

Process control

Action

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

Quantity

207 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

REF: BAR-IMPACTOR, P/N: 400906-A; UDI-DI: M906IMP1A0; Lot numbers: 10282203, 06152307, 08292301, 10112307.

510(k) numbers

not on file

PMA numbers

not on file

Product code

LXH

Firm FEI

3006232063

Firm city

Woburn

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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