TC-PLUS Tibial Insert UC 10 recallZ-0019-06 · Plus Orthopedics USA · initiated Aug 3, 2005
Terminated All recalls posted in October 2005
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 Plus Orthopedics USA 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
Did not meet specifications.
FDA root cause category: Other
What the company is doing
Recall was by scripted telephone conversations to two consignees. Products were returned under RMA.
Recall details
- Recall number
- Z-0019-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 3, 2005
- Posted by the FDA
- Oct 7, 2005
- Recalling firm
- Plus Orthopedics USA
- Quantity
- 3
- Product code
- JWH
- FDA submissions
- K000666
- Distribution
- Arizona, California, Idaho, New York, Texas, and Virginia
Product description
TC-PLUS Tibial Insert UC 10; 11mm, Model 25457
Code information (models, lots, serial numbers)
Lot code: 0501.13.0200
Other devices under the same FDA submission
3 devices cleared under K000666 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TC-PLUS 75005997Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- TC-PLUS 75006076Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- TC-PLUS 75005186Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 32882).
- Z-0013-06 · TerminatedTC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456
- Z-0014-06 · TerminatedTC-PLUS Tibial Insert 2; 15mm, Model 25309
- Z-0015-06 · TerminatedTC-PLUS Tibial Insert UC 4; 11mm, Model 25427
- Z-0016-06 · TerminatedTC-PLUS Tibial Insert UC 4; 13mm, Model 25428
- Z-0017-06 · TerminatedTC-PLUS Tibial Insert UC 6; 9 mm, Model 25436
- Z-0018-06 · TerminatedTC-PLUS Tibial Insert UC 6; 13mm, Model 25438
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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