Barricaid Annular Closure Impactor recalled due to missing welds
Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical device with a structural manufacturing defect (missing weld). Although no injuries or deaths have been reported, this constitutes a risk-of-harm medical device product without currently reported illness, meeting the criterion for High severity.
Plain-English summary
Intrinsic Therapeutics, Inc. is recalling 207 units of the Barricaid Annular Closure Impactor (REF: BAR-IMPACTOR, P/N: 400906-A) nationwide. The device is a surgical instrument used in spinal procedures.
The recall was issued due to a manufacturing defect: at least two units have been found to be missing a weld, a critical structural component. Affected lot numbers are 10282203, 06152307, 08292301, and 10112307.
Healthcare providers who have received this device should verify their inventory against the lot numbers. Patients with this device should contact their healthcare provider to determine if their implant may be affected. The missing weld could compromise structural integrity during use. No injuries or deaths have been reported as of the recall notice.
The recalled product
- Product
- Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
- Manufacturer
- Intrinsic Therapeutics, Inc.
- Affected units
- 207
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- REF: BAR-IMPACTOR
- P/N: 400906-A
- UDI-DI: M906IMP1A0
- Lot numbers: 10282203
- 06152307
- 08292301
- 10112307.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Intrinsic Therapeutics, Inc.
See all →- ModerateFDA Recalls Barricaid Annual Closure Devices Due to Labeling Error
FDA (Devices) · 2020-08-19
Other medical device recalls
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
Similar recalls
- ModerateFDA Recalls Barricaid Annual Closure Devices Due to Labeling Error
FDA (Devices) · 2020-08-19
- HighOffset Cup Impactor Surgical Instruments Recalled for Weld Fracture
FDA (Devices) · 2024-12-04
- HighImplantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- SevereICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
FDA (Devices) · 2020-10-28
- HighMedtronic Implantable Cardioverter Defibrillator Recalled Due to Weld Crack Defect
FDA (Devices) · 2024-07-03
- HighIntervertebral Fusion Device Recalled for Potential Packaging Defect
FDA (Devices) · 2023-08-30