Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks
Synthes (USA) Products LLC is recalling 212 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.
- Product
- SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
- Category
- Medical Device
- Distribution
- Distributed nationwide