Silicone MCP SMCP-500-20-WWRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556856895), received between Nov 14, 2023 and Aug 13, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A JOINT REPLACEMENT SURGERY, IT WAS NOTICED THAT THE STERILE PACKAGING OF ONE (1) SILICONE MCP SZ 20 WAS COMPROMISED, IT WAS PEELED. OUTER PACKAGING WAS IN FINE CONDITION AND NO DAMAGED IN SHIPPING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801153 ↗
• InjuryNov 14, 2023Break; Fracture; Material Deformation; Material Split, Cut or Torn; Break; Fracture; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, ONE YEAR LATER ONE (1) SILICONE PIP SZ AND TWO (2) UNKN MCP IMPL BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. CURRENT HEALTH STATUS OF PATIENT IS GOOD. THE PRIMARY SILICONE PIP SZ. 0 WAS IMPLANTED IN THE RING FINGER, AND THE SILICONE MCP PRODUCTS WERE IMPLANTED IN THE MIDDLE AND INDEX FINGER. THIS REPORTS COVERS THE FAILURE OF THE SILICONE MCP. 0 THAT WAS IMPLANTED IN THE INDEX FINGER.

  Patient problems: Failure of Implant

  MAUDE report 18132772 ↗
• InjuryNov 14, 2023Break; Fracture; Material Split, Cut or Torn; Break; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, ONE YEAR LATER ONE (1) SILICONE PIP SZ AND TWO (2) UNKN MCP IMPL BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. CURRENT HEALTH STATUS OF PATIENT IS GOOD. THE PRIMARY SILICONE PIP SZ. 0 WAS IMPLANTED IN THE RING FINGER, AND THE SILICONE MCP PRODUCTS WERE IMPLANTED IN THE MIDDLE AND INDEX FINGER. THIS REPORTS COVERS THE FAILURE OF THE SILICONE MCP. 0 THAT WAS IMPLANTED IN THE MIDDLE FINGER.

  Patient problems: Failure of Implant

  MAUDE report 18132664 ↗