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
FDA Recall Z-1343-04 · Posted 2004-08-14
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Recalling FirmSpinal Concepts, Inc
Recall StatusTerminated
Product CodeMQP
Date Initiated2004-04-01
Date Terminated2004-10-20
Product Quantity646 units
Reason for Recall
Handle becomes loose after repeated use.
Firm Action
Telephone calls were made 4/1/04 to consignees requesting inspection and return of the product.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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