Reported Dec 24, 2014 · Terminated

ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm…

4-Web Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: 4-Web Inc. · 6710 Reseach Rd. · Frisco, TX · 75033

Is this the product you have?

  • ASTS-LG1212Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12
  • mm height and ASTS-LG0612Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height
Lot codes and dates
  • Model ASTS-LG1212 serial numbers
    • AL23BA064
    • AL23BA065
    • AL23BA066
    • AL23BA067
    • AL23BA068
    • AL23BA069
    • AL23BA070
    • AL23BA071
    • AL23BA072
    • AL23BA073
    • AL23BA074
    • AL23BA075
    • AL23BA076
    • AL23BA077
    • AL23BA078
    • AL23BA079
    • AL23BA080
    • AL23BA081
    • AL23BA082
    • AL23BA083
    • AL23BA084
    • AL23BA085
    • AL23BA086
    • AL23BA087
    • AL23BA088
    • AL23BA089
    • AL23BA090
    • AL23BA091
    • AL23BA092
    • AL23BA093
  • Model ASTS-LG0612 serial numbers
    • AL13BA050
    • AL13BA051
    • AL13BA052
    • AL13BA053
    • AL13BA054
    • AL13BA055
    • AL13BA056
    • AL13BA057
    • AL13BA058
    • AL13BA059
    • AL13BA060
    • AL13BA061
    • AL13BA062
    • AL13BA063
    • AL13BA064
    • AL13BA065
    • AL13BA066
    • AL13BA067
    • AL13BA068
    • AL13BA069
    • AL13BA070
    • AL13BA071
    • AL13BA072
    • AL13BA073
    • AL13BA074
    • AL13BA075
    • AL13BA076
Amount recalled
35 units

Where it was sold

Why it was recalled

Product is mislabeled.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 27, 2016 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.