Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge… recallZ-1447-04 · Zimmer Inc. · initiated Aug 3, 2004
Terminated All recalls posted in September 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
FDA root cause category: Other
What the company is doing
Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.
Recall details
- Recall number
- Z-1447-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 3, 2004
- Posted by the FDA
- Sep 14, 2004
- Recalling firm
- Zimmer Inc.
- Product code
- KRO
- FDA submissions
- K013385
- Distribution
- Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.
Product description
Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02.
Code information (models, lots, serial numbers)
Lot 60037871; Exp. June 2008.
Other devices under the same FDA submission
36 devices cleared under K013385 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NexGen® 5880-16-02Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER16 reports
- NexGen® 5880-14-02Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- NexGen® 5880-15-01Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- NexGen® 5880-14-01Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- NexGen® 5880-16-01Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- NexGen® 5880-40-12Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- NexGen® 5880-60-12Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- NexGen® 5880-04Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- NexGen® 5880-50-12Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- NexGen® 5880-05Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NexGen® 5880-15-02Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NexGen® 5880-40-14Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 29832).
- Z-1448-04 · TerminatedZimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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