Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-
FDA device recall Z-1343-04 · posted 2004-08-14 · Terminated
Recall details
- Recalling firm
- Spinal Concepts, Inc
- Reason for recall
- Handle becomes loose after repeated use.
- Action taken
- Telephone calls were made 4/1/04 to consignees requesting inspection and return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 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
- Date initiated
- 2004-04-01
- Date posted
- 2004-08-14
- Date terminated
- 2004-10-20
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINAL CONCEPTS INC. CADENCE AND TRAXIS (K033517) | Spinal Concepts, Inc. | 2004-02-18 |