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.
What this means for you
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.
- Hazard
- missing-weld
- manufacturing-defect
- structural-defect
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.
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