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Terminated

VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

FDA Recall Z-0307-2008 · Posted 2008-01-09

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJDK
Date Initiated2007-09-19
Date Terminated2008-03-10
Product Quantity6 units.

Reason for Recall

Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

Firm Action

The recalling firm notified consignees of its recall via an Urgent Device Recall letter on 09/19/07. Consignees notified of a labeling error regarding device usage and were told they would be notified by a customer service rep to facilitate return of the recalled devices.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide: including direct accounts in CO, KS and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030608OTI BONE CEMENT PLUGOsteoimplant Technology, Inc. · 2003-06-12

Official Source

View FDA Recall →

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

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