Innomed, Inc. 4230-01Recalls & reported problems
Innomed, Inc. · Patella Cover Plate Small · Class 1
Data updated Oct 18, 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 00840277107817), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inadequate Instructions for Healthcare Professional1
- Missing Information1
- Use of Device Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2025Inadequate Instructions for Healthcare Professional; Use of Device Problem; Missing Information
ON 12/05/2024, STRYKER REPORTED (PR ID (B)(6)) TO INNOMED, INC. THAT STRYKER CATALOG #4230-01NM WAS MISPLACED DURING SURGERY BY THE SURGICAL TEAM. THE SURGICAL TEAM IDENTIFIED THE ISSUE VIA IMAGING AFTER THE PROCEDURE. THE PATIENT REQUIRED A SECOND SURGERY TO REMOVE THE PATELLA PLATE. AT THE TIME OF THE REPORT, NEITHER STRYKER NOR THE END USER HAD REPORTED THE EVENT AS MANDATED BY THE FDA MDR REQUIREMENTS. INNOMED, INC. REQUESTED THAT THE DEVICE BE RETURNED TO CONFIRM IT TO BE AN INNOMED DEVICE HAD PERFORM A PROPER EVALUATION. AFTER MULTIPLE REQUESTS BY INNOMED, INC., STRYKER REPORTED TO INNOMED, INC., THAT THEY COULD NOT OBTAIN THE DEVICE OR ANY ADD'L INFO FROM THE REPORTER. BASED ON THE LIMITED INFO PROVIDED, THERE IS NO INDICATION THAT THE DEVICE FAILED, AND INNOMED BELIEVES THE SURGICAL TEAM FAILED TO ACCOUNT FOR THE DEVICE BEFORE COMPLETING THE PROCEDURE, CAUSING ADD'L SURGERY TO RECOVER THE DEVICE. REF: INNOMED, INC. CUSTOMER FEEDBACK (B)(4) FOR DETAILS.
Patient problems: Failure of Implant
MAUDE report 21900699 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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