openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 9
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Code information
Size 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811
Distribution pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 2 of 9
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 3 of 9
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 4 of 9
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.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 5 of 9
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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
Distribution pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 6 of 9
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 7 of 9
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.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 8 of 9
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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
Distribution pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
device · product 9 of 9
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Code information
Size 8, includes the following Lot numbers: 370321 37213648 37216196 61424999 61543980 62029931 62390069
Distribution pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.