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Terminated

iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.

FDA Recall Z-1965-2009 · Posted 2009-09-03

Recalling FirmTheken Spine LLC
Recall StatusTerminated
Product CodeMQV
Date Initiated2008-08-26
Date Terminated2012-03-09
Product Quantity22 units

Reason for Recall

Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.

Firm Action

Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm. For further questions, contact Theken Spine, LLC at 1-330-475-8662.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution -- TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040134THERILINK BONE VOID FILLERTherics, Inc. · 2004-03-09

Official Source

View FDA Recall →

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

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