Z-1938-2014 Class II Terminated
FDA device recall Z-1938-2014 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 7. 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 7, includes the following Lot Numbers: 370320 37214653 61424998 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61827120 61827121 61827122 61979040 61979041 62051526 62091729 62200288 62227423 62251572 62330688 62383359 62383362 62401016 62401017 62602812 62602813 62640983
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1938-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026