Two Class I Designations Assigned to DePuy Synthes Recalls of CMF Distraction System Jaw-Stabilizing Device
Deaths Involved DePuy Synthes CMF. Parker Waichman LLP is reviewing claims concerning serious injuries and deaths involving the DePuy Synthes Craniomaxillofacial (CMF) Distraction System Jaw-Stabilizing device. DePuy Synthes is a unit of healthcare giant Johnson & Johnson. The DePuy Synthes CMF Distraction System (AB … [Read more...] about Two Class I Designations Assigned to DePuy Synthes Recalls of CMF Distraction System Jaw-Stabilizing Device
Highest-Risk Class I Label on St. Jude ICD CRT-D Recall
Class I Label On ICD CRT-D Recall. The U.S. Food and Drug Administration (FDA) has placed its most serious Class I label on a St. Jude Medical recall affecting hundreds of thousands of pacemakers prone to premature battery depletion. The devices in question are implantable cardioverter defibrillators (ICDs) and cardiac … [Read more...] about Highest-Risk Class I Label on St. Jude ICD CRT-D Recall
Baxter Says Peripheral Vascular Patch Recall was Due to Packaging
Baxter Recall Peripheral Vascular Patch. Baxter International, Inc. says new packaging is to blame for the Class I recall of its peripheral vascular patches, Qmed reports. Class I recalls are the most serious type of recall; they are reserved for recalls in which exposure to the drug can reasonably lead to serious health … [Read more...] about Baxter Says Peripheral Vascular Patch Recall was Due to Packaging
Class I Recall Announced for TigerPaw II Heart Device
Class I Recall For TigerPaw II Heart Device. This week, the Food and Drug Administration (FDA) announced the recall of the TigerPaw System II by Maquet Medical Systems. The TigerPaw II is an implantable left atrial appendage (LAA) occlusion device intended for use during heart surgery. The TigerPaw is a surgical staple … [Read more...] about Class I Recall Announced for TigerPaw II Heart Device
Class I Recall for Gyrus ACMI Ear Device
Gyrus ACMI Ear Device Are Being Recalled. The recalled device is intended to be implanted for ventilation or drainage of the middle ear. A Class I recall has been issued by Gyrus ACMI, Inc. for Micron Bobbin Vent Tube T, 1.27 mm. The recalled device is intended to be implanted for ventilation or drainage of the middle ear. Class I … [Read more...] about Class I Recall for Gyrus ACMI Ear Device
