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Terminated

Dynesys Revision + set screw

FDA Recall Z-0239-2013 · Posted 2012-11-06

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeNQP
Date Initiated2012-09-04
Date Terminated2014-04-16
Product Quantity1575

Reason for Recall

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Firm Action

Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043565MODIFICATION TO DYNESYS SPINAL SYSTEMZimmer Spine, Inc. · 2005-03-11K031511DYNESYS SPINAL SYSTEMCenterpulse Spine-Tech, Inc. · 2004-03-05

Official Source

View FDA Recall →

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

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