VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
Lot Codes / Batch Numbers
Lot #: U101.
Products Sold
Lot #: U101.
A medical device manufacturer is recalling VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedic due to 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 in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.....)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026