Johnson & Johnson’s (JNJ) DePuy Synthes Class I Recall
August 28, 2014
Johnson & Johnson DePuy Synthes Class I Recall
3D Printing (like on the image above) has been used for years in surgery when making Medical Models that cast an image of a patient’s head to help in pre-surgery planning of difficult cases; and, one such case is mandible distraction (or advancing on both planes (longer and outward) the lower jaw bone). Today it was announced that Johnson & Johnson (JNJ) subsidiary DePuy Synthes is Class I recalling several lot numbers of their Craniomaxilliofacial Distraction System (CMF) according to Reuters
FDA Class I Recall is the most severe recall and indicates there’s a probability the product will cause serious health problems or death. While the number of cases done annually are rather small*, it is the subset of patients that is cause for concern. Distraction cases are done on children (including infants) where the device remains outside of the skin for up to six months, and is extrememly painful. The goal of the surgery is to advance the mandible forward where parents, at home, are required to turn small screws on the outside under the direction of a maxilliofacial plastic surgeon. The idea that there’s a recall is heartbreaking to think a child may have to undergo another painful surgery if the previous device failed or caused harm.
*In 2000, I worked for a competitior to then Synthes (later sold to Johnson & Johnson’s DePuy division), Stryker Leibinger, and did about six of these cases over almost four years. In comparison for context (and not meant to diminish the importance of this recall) I did two-three trauma cases almost daily.
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