Z-1343-04

Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part...

Name: Z-1343-04 Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part...
Creator: Spinal Concepts, Inc
Published: 2004-04-01
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2004-04-01 / Terminated

FDA source

Spinal Concepts, Inc began a recall of 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... on 2004-04-01. The reason FDA records is "Handle becomes loose after repeated use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1343-04
Status: Terminated
Initiated: 2004-04-01
Posted: 2004-08-14
Terminated: 2004-10-20
Recalling firm: Spinal Concepts, Inc.
Product: 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
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: Handle becomes loose after repeated use.
FDA root cause: Other
Action: Telephone calls were made 4/1/04 to consignees requesting inspection and return of the product.
Quantity in commerce: 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
Product codes and lots: 2851-1-01 lot number 18YH, 2851-1-30 lot number 18YJ, 2851-2-01 lot number 18YK, 2851-2-30 lot number 18YL, 2851-3-01 lot number 18YM, 2851-3-30 lot number 18YP, 2851-4-01, lot number 18YQ, 2851-4-30 lot number 18YR, 2851-4-31 lot number 18YS, 2851-5-01 lot number 18YT, 2851-5-30 lot number 18YW, 2852-2 lot number 18YT, 2852-4 lot number 18YT, 2854-1 lot number 18YX, 2857-1 lot number 18YZ, 2857-2 lot number 18ZA, 2862-1 lot number 18YY, 2858-1 lot number 18ZB, 2859-1 lot number 18ZC, and 2861-5 lot number 18ZD

Product code MQP

K033517Class IISpinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. / cleared 2004-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)