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STAR™
Stryker GmbH · Model 99-0028/34 · UDI-DI 00886385019482
NTG
Prescription
0
510(k) clearances
1,692
Adverse events (18 deaths)
4
Recalls
20
Facilities
Description
Trial S.T.A.R. P.E. Core 14mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-24 | DT MedTech, LLC | Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device. |
| 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. |
| 2018-09-25 | DT MedTech, LLC | Incorrect package labeling identifying the device |
| 2018-09-25 | DT MedTech, LLC | Incorrect package labeling identifying the device |
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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.