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INFINITY
WRIGHT MEDICAL TECHNOLOGY, INC. · Model 33633208 · UDI-DI 00840420122179
HSN
Prescription
10
510(k) clearances
6,959
Adverse events (3 deaths)
47
Recalls
90
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-06 | Wright Medical Technology, Inc. | Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an inte |
| 2023-11-21 | Exactech, Inc. | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-06-13 | Wright Medical Technology, Inc. | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement thr |
| 2022-09-30 | Wright Medical Technology, Inc. | The tibial tray lock detail is oversized (larger than specification). |
| 2022-09-30 | Wright Medical Technology, Inc. | The tibial tray lock detail is oversized (larger than specification). |
| 2022-06-02 | Wright Medical Technology, Inc. | The instrument is incorrectly color coded. |
| 2021-11-04 | Wright Medical Technology Inc | The package contents and package labeling do not match. |
| 2021-11-04 | Wright Medical Technology Inc | The package contents and package labeling do not match. |
| 2021-08-30 | Exactech, Inc. | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2020-08-10 | Exactech, Inc. | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed B |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.