GENESIS II 71433443Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 3-4 10M · Class 1
All models of GENESIS II (462)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556479971), received between Jul 28, 2021 and Jul 28, 2021 — classified as 2 malfunctions.
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 16, 2026.
Most reported problems
Device problems
- Break2
- Naturally Worn2
- Scratched Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2021Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material
IT WAS REPORTED THAT, ONE (1) G2 DISH ART TR SZ7-8 11MM, ONE (1) G2 INS SPAC TR SZ7-8 13MM, FOUR (4) GII CR DEEP FLX ISR TR S3-4 10, THREE (3) GII CR DEEP FLX ISR TR S5-6 10, TWO (2) GII CR DEEP FLX ISR TR S7-8 10 AND TWO (2) GII CR DEEP FLX ISR TR S7-8 12 ARE OLD AND SCUFFED UP. AFTER VISUAL INSPECTION OF TWO GII CR DEEP FLX ISR TR S3-4 10 ((B)(4) AND (B)(4)) IT WAS FOUND THAT ARE CRACKED, RENDERING THEM INOPERABLE . NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12239620 ↗MalfunctionJul 28, 2021Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material
IT WAS REPORTED THAT, ONE (1) G2 DISH ART TR SZ7-8 11MM, ONE (1) G2 INS SPAC TR SZ7-8 13MM, FOUR (4) GII CR DEEP FLX ISR TR S3-4 10, THREE (3) GII CR DEEP FLX ISR TR S5-6 10, TWO (2) GII CR DEEP FLX ISR TR S7-8 10 AND TWO (2) GII CR DEEP FLX ISR TR S7-8 12 ARE OLD AND SCUFFED UP. AFTER VISUAL INSPECTION OF TWO GII CR DEEP FLX ISR TR S3-4 10 ((B)(4) AND (B)(4)) WERE FOUND TO BE CRACKED, RENDERING THEM INOPERABLE . NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12239612 ↗
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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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