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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNIVERSAL LOCKING BASE AND TRAY
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ZIMMER, INC. ZIMMER UNIVERSAL LOCKING BASE AND TRAY Back to Search Results
Catalog Number 00483608000
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2015
Event Type  malfunction  
Manufacturer Narrative
A technical evaluation confirmed that the cases had incorrect silk screening.A stock investigation was conducted and concluded that the issue was contained in this specific lot.The incorrect silk screening corresponds to implant part numbers that are not to be placed in the case due to the material composition.As a result, a recall is being initiated for this single lot of product.The above mentioned report number can be reviewed for additional information.
 
Event Description
It is reported that during a kit inspection, it was noticed that the silk screening on the implant cases had the incorrect identification numbers.
 
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Brand Name
ZIMMER UNIVERSAL LOCKING BASE AND TRAY
Manufacturer (Section D)
ZIMMER, INC.
p.o box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4961904
MDR Text Key23237488
Report Number1822565-2015-01403
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Remedial Action Recall
Report Date 07/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00483608000
Device Lot Number56555128
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/06/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/31/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction Number1822565-08-05-2015-009R
Patient Sequence Number1
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