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Terminated

Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.

FDA Recall Z-0155-05 · Posted 2004-11-03

Recalling FirmGE OEC Medical Systems,Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-09-15
Date Terminated2011-07-07
Product Quantity114 units

Reason for Recall

Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.

Firm Action

Consignees were notified by letter on 9/15/2004.

Root Cause

Other

Distribution Pattern

AL, CO, CA, FL, GA, LA, IL, IN, MA, MD, MI, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV, including one VA facility in TN. No military or foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040050INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500Ge Medical Systems Navigation and Visualization IN · 2004-03-24

Official Source

View FDA Recall →

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

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