Recall Z-2455-2023 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medicrea International
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
| Date | Aug 24, 2023 (initiated Jul 12, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| Root cause | Under Investigation by firm |
| Action | Beginning 12 July 2023, In the U.S. Medtronic disseminated an URGENT: MEDICAL PRODUCT RECALL to its consignees via UPS 2-Day delivery. The notice explained the problem, risk, and requested the following: Medtronic requests that you immediately take the following actions: Identify and quarantine any unused impacted product(s). Return all unused and non-expired product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applica |
| Quantity | 24 units |
| Distribution | US nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100544 | IMPIX LUMBAR INTERBODY DEVICE Medicrea Technologies, Jul 22, 2010 |