A.T.S.® 60-4009-101-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Single Hose with CPC Connectors · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024376786), received between Aug 29, 2023 and Jul 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 9, 2026Class IIOpen, Classified
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Z-2674-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Delivered as Unsterile Product2
- Manufacturing, Packaging or Shipping Problem2
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING INSPECTION, THE UNITS WERE FOUND TO BE NONCONFORMING, THERE WERE WRINKLES IN THE SEALING AREA, WHICH COMPROMISES THE STERILITY OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394989 ↗MalfunctionAug 29, 2023Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING RECEIVING/INSPECTION THAT THE INCOMING INSPECTION TEAM MEMBER FOUND HAIR LIKE DEBRIS IN THE STERILE PACKAGE. THERE WAS NO HARM OR INJURY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17642695 ↗MalfunctionAug 29, 2023Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING RECEIVING/INSPECTION THAT THE INCOMING INSPECTION TEAM MEMBER FOUND HAIR LIKE DEBRIS IN THE STERILE PACKAGE. THERE WAS NO HARM OR INJURY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17642668 ↗
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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 · each recall links to the FDA recall notice
- 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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