Recall Z-2688-2024 ยท LXH Orthopedic Manual Surgical Instrument
Intrinsic Therapeutics, Inc.
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
| Date | Aug 20, 2024 (initiated Jul 25, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 207 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.