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SANTA CLARA, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for the iFuse Bedrock Granite™ (Granite) system, used for ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
DePuy Synthes (/ d ə ˈ p j uː /) is a franchise of orthopaedic and neurosurgery companies.Acquired by Johnson & Johnson in 1998, its companies form part of the Johnson & Johnson MedTech business segment.
A Facebook group called Essure Problems which had 33,140 members (as of 04/03/2017) called the method "E-hell" and mentioned mostly pain, bleeding, bloating and other side effects from the device. Some women had coils break and perforate their internal organs, or conceived and gave birth to a child, at a number well above what Bayer has been ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. B. Braun Medical did not immediately respond to a Reuters request for comment.
Biomet manufactured reconstructive products for orthopedic surgery, such as hips, knees and shoulders, fixation devices, orthopedic support devices. It also made spinal implants, dental implants, and general operating instruments. Its subsidiary, Biomet Microfixation, manufactured mainly craniomaxillofacial and neurosurgical products. [7]
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