ZDRIVE™ 70-2001Recalls & reported problems
Biomet Microfixation, Inc · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036228514), received between Sep 4, 2019 and Sep 4, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Foreign Body In Patient
MAUDE report 8960948 ↗
Other MOTOR, SURGICAL INSTRUMENT, AC-POWERED devices
- NA 05.001.201Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,902 reports
- NA 530.710Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,800 reports
- NA 530.705Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,492 reports
- NA 530.715Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED390 reports
- NA 530.730Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED267 reports
- NA 05.001.240Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED262 reports
- KINCISE™ 1000-00-101Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED242 reports
- NA 530.791Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED84 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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