FDA Device Intelligence
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Stryker GmbH · Model 905-0064 · UDI-DI 00886385017136

NTG Prescription
0
510(k) clearances
1,692
Adverse events (18 deaths)
4
Recalls
20
Facilities

Description

Barrel Hole Twist Drill w, Stop

Recalls

DateFirmReason
2026-03-24DT MedTech, LLCThrough customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
2023-11-21Exactech, Inc.Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
2018-09-25DT MedTech, LLCIncorrect package labeling identifying the device
2018-09-25DT MedTech, LLCIncorrect package labeling identifying the device

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Data 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.