NA 5049-11Recalls & reported problems
Zimmer, Inc. · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Zimmer cement mixing system has 388 reports in the FDA database, with 4 injuries and no deaths. Most reports describe unsealed packaging. Reports rose to 218 in the last 12 months from 1 in the 12 months before. One recall is open, started in March 2026, over package seals that are incomplete, wrinkled, or peeling, which can compromise sterility and lead to infection.
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
- 389
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 389 adverse event reports that list this exact device (DI 00889024376564), received between Mar 27, 2020 and Aug 26, 2026 — classified as 5 injuries, 384 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (218 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Mar 30, 2026Open, Classified
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Z-1946-2026 · Root cause: Vendor change control · FDA record ↗
Most reported problems
Device problems
- Unsealed Device Packaging218
- Packaging Problem68
- Device Contaminated During Manufacture or Shipping62
- Manufacturing, Packaging or Shipping Problem40
- Adverse Event Without Identified Device or Use Problem1
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions327
- No Patient Involvement58
- No Consequences Or Impact To Patient3
- Medical device site infection1
Recent adverse event reports
The 25 most recent of 389 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent an initial knee procedure. A washout and liner exchange occurred approximately five and a half months post-implantation due to suspected prosthetic joint infection following a positive Synovasure test.Attempts have been made and no further information has been provided.
Patient problems: Medical device site infection
MAUDE report 50454180 ↗MalfunctionJun 30, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE DISTRIBUTORSHIP IDENTIFIED NONCONFORMING PRODUCT DUE TO THE PRESENCE OF A HAIR-LIKE SUBSTANCE IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25663844 ↗MalfunctionMay 14, 2026Packaging Problem
IT WAS REPORTED THAT DURING RECEIVING INSPECTION AT A DISTRIBUTORSHIP, PRODUCTS WERE FOUND TO BE NONCONFORMING DUE TO THE PRODUCT BEING CAUGHT IN THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167811 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151414 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151413 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151403 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151402 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151388 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151379 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151373 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151370 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151366 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151359 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151349 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151331 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151313 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151306 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151294 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151284 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151279 ↗MalfunctionMay 12, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PRODUCT WAS FOUND NON-CONFORMING AT THE DISTRIBUTORSHIP. THERE WERE ISSUES WITH THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151232 ↗MalfunctionMay 7, 2026Unsealed Device Packaging
IT WAS REPORTED THAT DURING STOCK INSPECTION, THE PACKAGE WAS FOUND TO BE NONCONFORMING WITH A NARROW SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25119564 ↗MalfunctionApr 28, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THERE WAS A WRINKLE IN THE SEAL. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019679 ↗MalfunctionApr 28, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THERE WAS A WRINKLE IN THE SEAL. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019562 ↗MalfunctionApr 16, 2026Unsealed Device Packaging
IT WAS REPORTED THAT DURING RECEIVING INSPECTION OF CEMENT BOWLS, THERE WERE ISSUES WITH THE SEALING AREA OF THE PACKAGING. THE DEFECTS WERE IDENTIFIED DURING INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896562 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.