EXPRESSEWRecalls & reported problems across all models
Medos International Sàrl · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,459
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls
- 0
We found 6 models of EXPRESSEW by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 2,459 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2013 and Sep 16, 2026 — classified as 60 injuries, 2,399 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (781 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. 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
Reports received per month, all models
Most reported EXPRESSEW problems
Device problems
- Detachment of Device or Device Component781
- Device-Device Incompatibility707
- Break660
- Mechanical Jam192
- Material Deformation178
- Difficult to Open or Close128
- Use of Device Problem106
- Material Twisted/Bent98
Patient problems
- No Clinical Signs, Symptoms or Conditions1,840
- No Consequences Or Impact To Patient458
- Not Applicable97
- Foreign Body In Patient61
- No Code Available11
- No Known Impact Or Consequence To Patient10
- No Patient Involvement6
- Tissue Damage6
EXPRESSEW models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EXPRESSEW 214141ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- EXPRESSEW 214140ORTHOPEDIC MANUAL SURGICAL INSTRUMENT483 reports
- EXPRESSEW 288233ORTHOPEDIC MANUAL SURGICAL INSTRUMENT389 reports
- EXPRESSEW 214124ORTHOPEDIC MANUAL SURGICAL INSTRUMENT224 reports
- EXPRESSEW 288235ORTHOPEDIC MANUAL SURGICAL INSTRUMENT151 reports
- EXPRESSEW 288234ORTHOPEDIC MANUAL SURGICAL INSTRUMENT46 reports
Recent EXPRESSEW adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Device Slipped; Difficult to Open or Close; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793411 ↗MalfunctionSep 16, 2026Break; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787944 ↗MalfunctionSep 15, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779851 ↗MalfunctionSep 14, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763279 ↗MalfunctionSep 14, 2026Break
It was reported that during an unspecified arthroscopic procedure, the EXPRESSEW III NEEDLE device, needle broke. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756208 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Material Deformation
It was reported that during an unknown surgery, when performing the first suturing step in tissue with the EXPRSEW III AC+ RTN PLATE device, the plate did not properly hold the suture. A second attempt was made and the plate released the thread. On inspection, the plate tip was slightly raised and therefore did not retain the thread. The specialist used another retaining plate, which worked properly. There were no delays to the surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718037 ↗MalfunctionSep 8, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676867 ↗MalfunctionSep 1, 2026Break; Use of Device Problem; Illegible Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550293 ↗MalfunctionSep 1, 2026Break; Use of Device Problem; Illegible Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550288 ↗MalfunctionJul 9, 2026Device-Device Incompatibility; Difficult to Open or Close; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766207 ↗MalfunctionJun 24, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, THE EXPRSEW III AC+ RTN PLATE 1EA COULD NOT BE ATTACHED TO AUTOCAPUTURE EVEN THOUGH IT WAS USED IN A NORMAL WAY. THE SURGERY WAS COMPLETED WITH NO ISSUES USING NEW IMPLANT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25615640 ↗MalfunctionJun 23, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE EXPRESS CAME OFF THE MAIN UNIT. THE SURGERY WAS COMPLETED WITH NO ISSUES USING ANOTHER PRODUCT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598212 ↗MalfunctionJun 17, 2026Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE EXPRSEW III AC+ RTN PLATE DEVICE THE PLATE WOULD NOT FIX TO THE INSTRUMENT AND BECAME STUCK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538116 ↗MalfunctionJun 17, 2026Device Slipped; Device-Device Incompatibility
IT WAS REPORTED THAT THE EXPRESSEW III W/HOOK DEVICE HAD A FAULTY GRASPING MECHANISM. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE UPPER JAW WAS LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25533383 ↗MalfunctionJun 16, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A SHOULDER GREATER TUBERCLE FRACTURE REPAIR PROCEDURE THE EXPRSEW III AC+ RTN PLATE DEVICE COULD NOT BE ATTACHED AND COME OFF EVEN THOUGH IT WAS PERFORMED CORRECTLY . ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523785 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
- GRYPHON ORTHOCORD6 models · 918 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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