Recall Z-0129-2014— Zimmer, Inc.

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-08-28, terminated 2015-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.. Reason: Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing, to provide statisti.

Recalling firm

Zimmer, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-08-28

Terminated

2015-04-30

Firm location

Warsaw, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.