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: A Georgia Lawyer

Vertebral Body Replacement Recall - Georgia/Florida News

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I wrote about the recall in a prior post. Here's the lot information:

The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:

? Part No. 04.808.001; Description: Ti Synex (TM) II Central Body 14 mm ? 19 mm
? Part No. 04.808.002; Description: Ti Synex (TM) II Central Body 17 mm ? 25 mm
? Part No. 04.808.003; Description: Ti Synex (TM) II Central Body 21 mm ? 29 mm
? Part. No.04.808.004; Description: Ti Synex (TM) II Central Body 25 mm ? 33 mm
? Part No. 04.808.005; Description: Ti Synex (TM) II Central Body 29 mm ? 44 mm
? Part No. 04.808.006; Description: Ti Synex (TM) II Central Body 37 mm ? 52 mm
? Part No. 04.808.007; Description: Ti Synex (TM) II Central Body 45 mm ? 71 mm
? Part No. 04.808.008; Description: Ti Synex (TM) II Central Body 58 mm ? 84 mm
? Part No. 04.808.009; Description: Ti Synex (TM) II Central Body 71 mm ? 97 mm
? Part No. 04.808.010; Description: Ti Synex (TM) II Central Body 84 mm -110 mm
? Part No. 04.808.011; Description: Ti Synex (TM) II Central Body 97 mm -123 mm

Class 1 recalls are the FDA?s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Full post as published by A Georgia Lawyer on November 18, 2009 (boomark / email).