Reported Nov 13, 2013 · Terminated
Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- 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.
- Lot codes and dates
116 of 116 codes
003658880036641460004449601463836018634560197210602086986028243160389889604051086040793160869220610806936132794861375455617546566192392260004450602086996027671160282432608692216108069461391007600241746108069561328382613754576142160224416600600848466015468360186372601972116019909860266079602660806027969260373565604051096040793260415506604288066058695360725599610413116126126961287734613098316139100861698392617327706193354560024175601463866018637360197212602087026104131361375459
- Amount recalled
- 2,632 devices
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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