FDA (Devices) recall action 68457

Zimmer, Inc. recalled 9 products on 2014-07-09

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2014-07-09
Critical: 0
Units: 370,620

Why these products were recalled

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
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.
Category
Distribution
0 states