Recall Z-1343-04 ยท MQP Spinal Vertebral Body Replacement Device
Spinal Concepts, Inc
Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2862-1, 2858-1, 2859-1, and 2861-5
| Date | Aug 14, 2004 (initiated Apr 1, 2004) |
| Status | Terminated |
| Reason | Handle becomes loose after repeated use. |
| Root cause | Other |
| Action | Telephone calls were made 4/1/04 to consignees requesting inspection and return of the product. |
| Quantity | 646 units |
| Distribution | Product was distributed domestically in the following states: TN, MI, KY, CA, CO, OH, KS, WA, TX, NY, AZ, PA, MA, UT, MO, IN, NV, OR, SD, IL, NJ, WI, OK, FL, GA, VA, NC, MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS Spinal Concepts, Inc., Feb 18, 2004 |