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Serena Fixed Hinge
SERENA SLEEP SOLUTIONS LLC · Model Serena Fixed Hinge · UDI-DI 00850085577009
LRK
Prescription
1
510(k) clearances
2,628
Adverse events (1 deaths)
10
Recalls
108
Facilities
Description
Serena Fixed Hinge
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-27 | Prismatik Dentalcraft, Inc. | Due to device not having FDA Clearance |
| 2025-10-09 | Myofunctional Research Company USA | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. |
| 2022-05-23 | Dental Choice Holding Llc | The device was marketed and sold in the US without FDA clearance. |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently place |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.