CHARNLEYRecalls & reported problems across all models
Depuy International Ltd · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of CHARNLEY by Depuy International Ltd in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2019 and May 24, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (5 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
CHARNLEY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 27, 2014Terminated
The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
Z-0061-2015 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported CHARNLEY problems
Device problems
- Break5
- Detachment of Device or Device Component1
- Entrapment of Device1
- Loose or Intermittent Connection1
- Material Integrity Problem1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Not Applicable3
- No Consequences Or Impact To Patient2
CHARNLEY models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CHARNLEY 9620-04-000RETRACTOR1 recall2 reports
- 3 reports
- CHARNLEY 9620-06-000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- CHARNLEY 9620-20-000REAMER1 report
- CHARNLEY 9620-45-000CURETTE1 report
Recent CHARNLEY adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2023Material Integrity Problem; Material Integrity Problem
THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16990955 ↗MalfunctionMay 31, 2022Break; Break
CHARNLEY PINS BROKE MID CASE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14549904 ↗MalfunctionFeb 22, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THESE INSTRUMENTS ARE BEING REPORTED FOR NATURAL WEAR AND TEAR. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577122 ↗MalfunctionMar 18, 2020Break; Entrapment of Device; Break; Entrapment of Device
END OF PIN RETAINED IN PATIENT DURING SURGERY, NOTED IN XRAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9848554 ↗MalfunctionMar 14, 2019Break; Break
MalfunctionMar 7, 2019Break; Break
WE HAD A PROBLEM WITH 3 DIFFERENT GIGLI SAWS ON FRIDAY AFTERNOON.
Patient problems: Not Applicable
MAUDE report 8398818 ↗MalfunctionMar 7, 2019Break; Break
WE HAD A PROBLEM WITH 3 DIFFERENT GIGLI SAWS ON FRIDAY AFTERNOON.
Patient problems: Not Applicable
MAUDE report 8398778 ↗MalfunctionFeb 20, 2019Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component
T-BAR HAS DIS-ASSEMBLED FROM THE INSTRUMENT (T-BAR NOT BROKEN).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8353760 ↗
Other Depuy International Ltd products
All Depuy International Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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