Innomed, Inc. 4535-RRecalls & reported problems
Innomed, Inc. · Modified Hohmann Retractor Narrow Ortholucent (C531) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840277108098), received between Nov 19, 2018 and Nov 19, 2018 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2018Break; Break
UF/IMPORTER REPORT # (B)(4) WAS RECEIVED AT INNOMED, INC. FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH ON (B)(4) 2018 WITH THE FOLLOWING EVENT DESCRIPTION DOCUMENTED: "TIP OF CARBON FIBER HOHMANN RETRACTOR BROKE DURING ANTERIOR APPROACH TOTAL HIP SURGERY. ENTIRE SURGERY WAS DONE UNDER FLUOROSCOPY. NO EVIDENCE OF RETAINED FOREIGN OBJECT IN PATIENT. HOHMAN WAS SEQUESTERED AND REMOVED FROM SERVICE". RESPONSE: AN EMAIL WAS SENT TO THE USER FACILITY'S CONTACT ON (B)(4) 2018 REQUESTING TO HAVE THE DEVICE FORWARDED TO INNOMED FOR INSPECTION AND EVALUATION. RETURN MERCHANDISE AUTHORIZATION (B)(4) AND A STERILIZATION CONFIRMATION FORM WAS ALSO SENT TO THE CONTACT BY INNOMED ON THE ABOVE REFERENCED DATE. THE DEVICE WAS RECEIVED AT INNOMED ON 11/8/2018. THE INTERNAL COMPLAINTS DATABASE WAS SURVEYED FOR THE DESCRIBED ISSUE ASSOCIATED WITH 4535-R, MODIFIED HOHMANN RETRACTOR-RADIOLUCENT. THE SURVEY ALSO INCLUDED REVIEW OF COMPLAINTS OF RETRACTORS SIMILAR IN DESIGN AND FUNCTION: 4550-R, MODIFIED BLUNT HOHMANN RETRACTOR-RADIOLUCENT, 4558-R, HOHMANN RETRACTOR 16MM RADIOLUCENT, AND 7110-R, ORTHOLUCENT BENT HOHMANN RETRACTOR. AFTER RECEIPT AT INNOMED, THE DEVICE WAS INSPECTED AND EVALUATED BY
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8086985 ↗
Other Retractor devices
- Endo Paddle Retract 173046Covidien LP · RETRACTOR56 reports
- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 11303RIntegra Lifesciences Corporation · RETRACTOR1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page