FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
- Recall number
- Z-0308-2008
- 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.
- Status
- Terminated
- Initiated
- 2007-09-19
- Posted
- 2008-01-09
- Terminated
- 2008-03-10
- Reason
- 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
- 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
- 6 units.
- Distribution
- Nationwide: including direct accounts in CO, KS and TX.
- Lot, serial or model codes
- Lot #: U103 and U171.
- 510(k) numbers
- ["K030608"]
- PMA numbers
- not on file
- Product code
- JDK
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28