Z-1937-2014 Class II Terminated
FDA device recall Z-1937-2014 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 6. 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 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1937-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026