WasherLocRecalls & reported problems across all models
Biomet Orthopedics, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of WasherLoc by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2022 and Nov 11, 2022 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (13 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
Most reported WasherLoc problems
Device problems
- Tear, Rip or Hole in Device Packaging13
- Packaging Problem6
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
WasherLoc models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WasherLoc™ 908644FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE15 reports
- WasherLoc™ 908646FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- WasherLoc™ 908648Screw, fixation, bone2 reports
- WasherLoc™ 908840Screw, fixation, bone1 report
Recent WasherLoc adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE SLEEVE INSIDE OF THE STERILE POUCH HAS ALREADY BEEN CRUSHED OR BROKEN. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15784338 ↗MalfunctionNov 10, 2022Packaging Problem; Packaging Problem
UPON VISUAL EVALUATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE STERILITY OF THE INNER POUCH HAS NOT BEEN BREACHED. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15770853 ↗MalfunctionNov 10, 2022Packaging Problem; Packaging Problem
UPON VISUAL EVALUATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE STERILITY OF THE INNER POUCH HAS NOT BEEN BREACHED. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15770838 ↗MalfunctionNov 10, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CLINIC DID A STOCK CHECK AND FOUND THE SLEEVE INSIDE OF STERILE POUCH WAS BROKEN OR CRUSHED. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15770832 ↗MalfunctionNov 10, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CLINIC DID A STOCK CHECK AND FOUND THE SLEEVE INSIDE OF STERILE POUCH WAS BROKEN OR CRUSHED. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15770769 ↗MalfunctionNov 2, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15716463 ↗MalfunctionAug 10, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHEN THE IMPLANT WAS REMOVED FROM THE PACKAGE THERE WAS A RIP CAUSING THE IMPLANT TO FALL ON THE GROUND. THEREFORE, THE PRODUCT WAS NOT USED. THERE WAS NO HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15197956 ↗MalfunctionMar 1, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE SLEEVE INSIDE OF THE STERILE POUCH WAS FOUND DAMAGED. THERE WAS NO BACKUP PRODUCT TO USE INSTEAD, SO THE SURGEON USED THE SAME DEVICE TO SUCCESSFULLY COMPLETE THE SURGERY. PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636129 ↗MalfunctionJan 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED. THE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13369013 ↗MalfunctionJan 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13155974 ↗MalfunctionJan 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153459 ↗MalfunctionJan 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153428 ↗MalfunctionJan 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153419 ↗MalfunctionJan 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153418 ↗MalfunctionJan 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153417 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
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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