Z-1935-2014 Class II Terminated
FDA device recall Z-1935-2014 was initiated by Zimmer, Inc. on May 19, 2014 and is designated Class II. Reason for recall: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. The recall status is terminated (terminated Oct 29, 2015). Affected quantity: 41,180 total.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 9, 2014
- Initiation Date
- May 19, 2014
- Termination Date
- Oct 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41,180 total
Product Description
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Reason for Recall
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
Code Information
Size 4+, includes the following Lot numbers: 61424996 61459959 61475129 61538052 61563971 61573791 61573792 61592090 61627207 61685463 61721674 61774165 61863139 61870152 61934692 61935096 61979044 61979045 62020278 62064940 62091727 62214673 62251567 62251568 62319307 62337924 62369795 62401020 62423841 62436412 62471736 62602816 62646169
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1935-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026