Osteotec Silicone Finger Implant - Size 4 OSTF-4Recalls & reported problems
Osteotec Limited · The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060183090057), received between Dec 5, 2025 and Dec 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jun 18, 2025Class IIOpen, Classified
There is the potential that the silicone implant may contain foreign material
Z-2222-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Break; Fracture; Break; Fracture
SALES MANAGER REPORTED ON 05NOV2025 THAT AN OSTF-4 HAD TO BE REMOVED DUE TO THE IMPLANT BREAKING. IT WAS STATED THAT THE INITIAL CASE TOOK PLACE ON (B)(6) 2025 BUT NEEDED REVISION SURGERY ON (B)(6) 2025. THE SURGEON ULTIMATELY IMPLANTED A SECOND OSTF-4 WITH NO ISSUE. THE SURGEON WAS NOT UPSET ABOUT THE IMPLANT AND TRIED TO COLLECT INFORMATION IF THE PATIENT FELL OR WHAT HAPPENED, HOWEVER, THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE PATIENT. A PHOTOGRAPH OF THE FRACTURED IMPLANT WAS PROVIDED, AND THE DEVICE HAS BEEN MADE AVAILABLE FOR RETURN AND EVALUATION. AT THIS STAGE, NO FURTHER INVESTIGATION OR FAILURE ANALYSIS DETAILS ARE AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL MDR IF RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729737 ↗
Other Prosthesis, Finger, Constrained, Polymer devices
- Osteotec Silicone Finger Implant - Size 3 OSTF-3Osteotec Limited · Prosthesis, Finger, Constrained, Polymer1 recall0 reports
- Osteotec Silicone Finger Implant - Size 5 OSTF-5Osteotec Limited · Prosthesis, Finger, Constrained, Polymer1 recall0 reports
- NA PIP-30Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER27 reports
- NA PIP-20Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER21 reports
- NA MCP-30Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA PIP-10Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA MCP-50Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER14 reports
- NA MCPX-40Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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