Quik-Use® 5049-53Recalls & reported problems
Zimmer, Inc. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024376625), received between Mar 27, 2023 and Dec 2, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem2
- Device Contaminated During Manufacture or Shipping1
- Manufacturing, Packaging or Shipping Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT HAIR-LIKE DEBRIS WAS FOUND IN THE PACKAGING DURING INSPECTION OF CIRCULATED STOCK ITEMS. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693820 ↗MalfunctionJun 21, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING INCOMING INSPECTION, DEBRIS WAS FOUND IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17171438 ↗MalfunctionJun 14, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT SCRATCHES WERE FOUND ON THE STERILE SEAL, WITH NO BREACH IN STERILITY OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17123760 ↗MalfunctionMar 27, 2023Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16618919 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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