Z-1079-2014 Class II Terminated
FDA device recall Z-1079-2014 was initiated by Zimmer, Inc. on Oct 17, 2013 and is designated Class II. Reason for recall: As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to… The recall status is terminated (terminated Sep 12, 2014). Affected quantity: 73,002 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 5, 2014
- Initiation Date
- Oct 17, 2013
- Termination Date
- Sep 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73,002 units
Product Description
Trabecular Metal" Reverse Shoulder System
Reason for Recall
As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.
Code Information
61025613, 61009830, 61038635, 61031385, 61021507, 61021506, 61016907, 61009834, 61006493, 61006492, 60999239, 60993837, 60993836, 60987295, 60982839, 60982838, 60970974, 60970973, 60950253, 60964425, 60946627, 60970946, 60964426, 60943695, 60940448, 60950251, 60946624, 60940449, 60927405, 60934492, 60900542, 60927406, 60919029, 60914617, 60919028, 60900543, 60893180, 60893181, 60906211, 60887745, 60887744, 60875337, 60875336, 60868040, 60873954, 60868041, 60867386, 60867385, 60856882, 60856880, 60855532, 60852815, 60855529, 60846158, 60846157, 60840619, 60834839, 60806512, 60824952, 60820211, 60814537, 60785523, 60795705, 60792083, 60761203, 60752933, 60781096, 60776583, 60765951, 60768804, 60757206, 60747093, 60741590, 60747092, 60741589, 60738183, 60727960, 60738184, 60730072, 60730073, 60723302, 60723277, 60718989, 60712568, 60683321, 60675599, 60669310, 60674468, 105533, 60605155, 105588, 60577323, 60580942, 60572796, 60564704, 60572798, 60568536, 60568535, 60578677, 60568468, 60568467, 60568466, 60564623, 60564639, 60564628, 60564641, 60564638, 60564636, 60568470, 60564642, 60564635, 60564625, 60564621, and 60564633.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1079-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026