M6-c Artificial Cervical Disc, Spinal Kinetics Llc: New Monitoring Requirements For The Risk Of Osteolysis (dsi/2026/001)
Summary The M6-C artificial cervical disc, used in neck spine surgery, is subject to new monitoring requirements in the UK due to reported cases of bone loss (osteolysis) and early device failure. Patients who have received this implant should be aware of these new monitoring protocols. The UK health authority is implementing these requirements based on safety assessments of reported cases in medical literature.
- Reason
- The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.
- Classification
- Unclassified
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2026-01-15
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/13a8896d-f00d-4f7b-a23e-02e256583cfb