Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.

FDA Recall Z-0190-2010 · Posted 2009-11-12

Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2009-05-13
Date Terminated2009-11-13
Product Quantity37 devices

Reason for Recall

Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.

Firm Action

Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080699NOVEL SPINAL SPACER SYSTEMAlphatec Spine, Inc. · 2008-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑