KeriFlex 210-P20002Recalls & reported problems
Keri Medical SA · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640181160662), received between May 15, 2026 and May 15, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Implant Pain1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT ARTHROPLASTY ON MARCH 2025; SUBSEQUENTLY ON (B)(6) 2026, THE PATIENT REPORTED PAIN AND A CLICKING SENSATION WHEN MOVING THE FINGER, ALONG WITH SWELLING AND SLIGHT DEVIATION. THE PATIENT UNDERWENT A REVISION SURGERY FOLLOWING BREAKAGE OF THE KERIFLEX PIP 2 IMPLANT. IT WAS REPORTED THAT THE IMPLANT FRACTURED AT THE HINGE POINT. DURING THE REVISION PROCEDURE, THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW KERIFLEX PIP 2 IMPLANT.
Patient problems: Implant Pain; Swelling/ Edema
MAUDE report 25182894 ↗
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- NA PIP-30Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER27 reports
- NA PIP-20Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER21 reports
- NA PIP-10Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA MCP-30Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER16 reports
- NA MCP-50Stryker GmbH · PROSTHESIS, FINGER, CONSTRAINED, POLYMER14 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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