Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall
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Date of Recall:
Thursday, November 12th, 2009
Recall Details:
On September 23, 2009, the company notified hospitals and sales consultants about this recall by mail. The company:
- identified the recalled product
- described the problem and potential health effects
- provided instructions to their customers to return all products in their inventory and all surgically removed devices for evaluation.
- notified and provided instructions to physicians and patients (through their physicians)
On November 09, 2009, the company sent physicians a follow up letter for their patients.
Class 1 recalls are the 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.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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