Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6120A QTY 1 BIO-ANCHOR, PRE-LOADED 3.5mm x 10.5 mm ***STERILE ***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA.***''
FDA Recall Z-1549-05 · Posted 2005-09-21
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Recalling FirmLinvatec Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2005-02-22
Date Terminated2012-07-07
Product Quantity1,764 Units
Reason for Recall
Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.
Firm Action
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
Root Cause
Other
Distribution Pattern
Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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