Z-0308-2008

VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore Orthopedics...

Name: Z-0308-2008 VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore Orthopedics...
Creator: Encore Medical, Lp
Published: 2007-09-19
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2007-09-19 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758 on 2007-09-19. The reason FDA records is "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.....)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0308-2008
Status: Terminated
Initiated: 2007-09-19
Posted: 2008-01-09
Terminated: 2008-03-10
Recalling firm: Encore Medical, LP
Product: VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
Product code: JDK Prosthesis, Hip, Cement Restrictor
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.....)
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 6 units.
Distribution: Nationwide: including direct accounts in CO, KS and TX.
Product codes and lots: Lot #: U103 and U171.

Product code JDK

K030608Class IIOti Bone Cement PlugOsteoimplant Technology, Inc. / cleared 2003-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)