Z-2688-2024Class II

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

Name: Z-2688-2024 Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Creator: Intrinsic Therapeutics, Inc.
Published: 2024-07-25
License: https://open.fda.gov/license/

Intrinsic Therapeutics, Inc. / initiated 2024-07-25 / Open, Classified / root cause: manufacturing process

FDA source

Intrinsic Therapeutics, Inc. began a recall of Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A on 2024-07-25. FDA classified it as Class II and gives the reason as "At least two units have been found to be missing a weld". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2688-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-25
Posted: 2024-08-20
Recalling firm: Intrinsic Therapeutics, Inc.
Product: Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: At least two units have been found to be missing a weld.
Root cause tag: manufacturing process
FDA 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 in commerce: 207 units
Distribution: US Nationwide distribution.
Product codes and lots: REF: BAR-IMPACTOR, P/N: 400906-A; UDI-DI: M906IMP1A0; Lot numbers: 10282203, 06152307, 08292301, 10112307.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2688-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2688-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-20

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)