SPECIALIST 96-6110Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 FEMORAL LOCATING DEVICE · Class 1
All models of SPECIALIST (80)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist femoral locating device is a surgical tool used to position the femur. The 24 reports mostly describe parts breaking, incompatibility with other devices, and sticking or difficulty moving, with no deaths or injuries reported. No recalls name this device; reports fell from 2 in the previous 12 months to 0 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295246831), received between Feb 28, 2018 and May 13, 2025 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Break” (10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break10
- Device-Device Incompatibility8
- Naturally Worn2
- Physical Resistance/Sticking2
- Detachment of Device or Device Component1
- Device Slipped1
- Difficult to Insert1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient10
- Insufficient Information3
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE INSTRUMENT WAS REPORTED FOR UNKNOWN ALLEGATION. THE ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013526 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED THAT SCREW HOLDING THE LOCKING MECHANISM BROKE AND CAN'T BE ADJUSTED.
Patient problems: Insufficient Information
MAUDE report 21691101 ↗MalfunctionAug 28, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: - DID NOT BREAK INTO TWO OR MORE PIECES. - NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091531 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THAT DISTAL FEMORAL CUT GUIDE BROKE. THERE WAS NO SURGICAL DELAY. ALL PIECES RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19930987 ↗MalfunctionApr 9, 2024Break; Break
THE SPRING ON THE DEVICE HAS BROKEN, WHICH NOW MAKES THE DEVICE UNUSABLE. NO HARM TO PATIENT AND NO DELAY TO SURGERY OCCURRED AS A RESULT OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070946 ↗MalfunctionMar 12, 2024Break; Break
IT WAS REPORTED THAT THE BEARINGS BROKE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18891561 ↗MalfunctionAug 3, 2023Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement
IT WAS REPORTED THAT AT THE BEGINNING OF THE SURGERY, DAMAGE TO THE VARUS/VALGUS GUIDE WAS OBSERVED. IT DID NOT AFFECT THE SURGERY AT ANY TIME SINCE THE VARUS/VALGUS GUIDE WAS USED IN THE SAME WAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17451233 ↗MalfunctionJun 7, 2023Device-Device Incompatibility; Device-Device Incompatibility
BLIND UNIT RECEIVED IN LOCAL STOCK MARKED WITH RED TAPE WITHOUT PC IDENTIFICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17081017 ↗MalfunctionJun 21, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ROD STOPS ARE WORN DOWN AND NO LONGER PREVENT REMOVAL FROM DISTAL FEMORAL JIG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14754124 ↗MalfunctionJun 2, 2022Break; Break
THE FEMORAL JIG BROKE. NOTICED AFTER IT WAS USED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14572220 ↗MalfunctionApr 7, 2022Break; Break
IT WAS REPORTED THAT INSTRUMENT WAS FOUND BROKEN AFTER DECONTAMINATION. ALL PIECES OF THE INSTRUMENT ARE TOGETHER AND WILL BE RETURNED IN THE SAME PACKAGE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14043298 ↗MalfunctionDec 8, 2021Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: Insufficient Information
MAUDE report 12960082 ↗MalfunctionAug 16, 2021Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE DEVICE BROKE WHEN PUTTING IT TOGETHER. IT FELL APART BEFORE IT WAS USED ON A PATIENT. THERE WAS A 2-MINUTE SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 12325372 ↗MalfunctionOct 23, 2020Break; Break
MalfunctionOct 2, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PIN FELL OUT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10620229 ↗MalfunctionMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility
INSTRUMENTS WHERE REALLY HARD TO PUT TOGETHER AND REQUIRED SOME FORCE TO GET THE CUTTING BLOCK ALIGNED INTO THE CORRECT POSITION. WHEN THE SURGEON WENT TO REMOVE THE JIG TO LEAVE BEHIND THE DISTAL FEMORAL CUTTING BLOCK, IT COULDN'T ALLOW THE JIG TO SLIDE OUT OF THE CUTTING BLOCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10067556 ↗MalfunctionJan 19, 2020Device-Device Incompatibility; Device-Device Incompatibility
MalfunctionDec 16, 2019Device-Device Incompatibility; Packaging Problem; Device-Device Incompatibility; Packaging Problem
IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE SP*2 FEMORAL LOCATING DEVICE IS NO LONGER LOCKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9475474 ↗MalfunctionNov 8, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
PRODUCT NAME: SIGMA KNEE CUTTING BLOCK. PRODUCT CODE: 96-6110. EVENT: DEVICE CANNOT BE MOVED TO THE RIGHT OR LEFT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9295815 ↗MalfunctionOct 23, 2019Device-Device Incompatibility; Device-Device Incompatibility
THE LOCKING MECHANISM ON INSTRUMENT #966110JJO (SN (B)(4)) CAN SOMETIMES UNLOCK WHEN THE BONE IS HARD (BECAUSE THERE ARE MORE VIBRATION).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9224435 ↗MalfunctionOct 8, 2019Device Slipped; Naturally Worn; Device Slipped; Naturally Worn
THE FEMORAL GUIDE(966110) DOES NOT KEEP WELL THE ANGLE DUE TO WEAR. STILL FUNCTIONING, BUT GETTING LOOSE AND SLACK. IT DID NOT CREATE ANY ISSUE YET, BUT IT WILL SOON.
Patient problems: Not Applicable
MAUDE report 9167185 ↗MalfunctionMay 30, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking
IT WAS REPORTED THAT THE INTERMEDULLARY ROD AND FEMORAL LOCATING DEVICE ARE STUCK TOGETHER. NEEDS REPLACEMENT TO P1 (B)(6) HOSPITAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8655883 ↗MalfunctionDec 3, 2018Break; Break
IT WAS REPORTED THAT THE COMPONENTS OF FEMORAL LOCATING DEVICE FOR SPEC2 INSTRUMENT CAME APART, ALL PARTS RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8124123 ↗MalfunctionFeb 28, 2018Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE TWO PIECES ARE NOT MATING TOGETHER AND NEED TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7302315 ↗
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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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