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Terminated

2.0 mm Inion CPS, C-plate, 7 holes, REF PLT-1017, sterile, Manufacturer, INION Oy, Finland.

FDA Recall Z-0646-2011 · Posted 2010-12-16

Recalling FirmStryker Craniomaxillofacial Division
Recall StatusTerminated
Product CodeJEY
Date Initiated2010-04-14
Date Terminated2012-06-06
Product Quantity8,631 all products

Reason for Recall

Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.

Firm Action

Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2010. The notice informed users of the change in the instructions for use (IFU), and included a copy of the revised IFU. The consignees were informed that the affected product does not need to be returned. Stryker can be contacted about this action at 877-534-2464 (option "Regulatory Affairs", reference Product Field Action #2009-445)

Root Cause

Other

Distribution Pattern

Nationwide Distribution: Throughout the US

Official Source

View FDA Recall →

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

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