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Terminated

ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height

FDA Recall Z-0812-2015 · Posted 2014-12-16

Recalling Firm4-Web Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2014-09-29
Date Terminated2016-06-27
Product Quantity35 units

Reason for Recall

Product is mislabeled.

Firm Action

4Web Medical sent an Urgent Medical Device Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm does not require any action to be performed by the consignees.The firm plans to label the remaining recalled lot not distributed as , "samples". Please contact 4Web Customer Service for questions and support. Phone: (1-800) 285-7090 Hours: Monday through Friday, 8:00am to 5:00pm Central Standard time.

Root Cause

Labeling mix-ups

Distribution Pattern

US Distribution including the states of TX, MT, DC, CA, IL, and MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1123164-WEB ALIF SPINAL TRUSS SYSTEM (STS)4-Web, Inc. · 2011-12-14

Official Source

View FDA Recall →

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

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