Awl 70.08.89Recalls & reported problems
Zimmer GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024301788), received between Oct 2, 2019 and Feb 12, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2021Fracture; Fracture
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11320492 ↗InjuryOct 2, 2019Fracture; Fracture
Other AWL devices
- Meridian RA2-003015Seaspine Orthopedics Corporation · AWL1 recall1 report
- AMP 117-165Alphatec Spine, Inc. · AWL1 recall0 reports
- SYNFIX Evolution 03.835.032Synthes GmbH · AWL16 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · AWL7 reports
- NA 359.213Synthes GmbH · AWL7 reports
- NA 03.820.100Synthes GmbH · AWL6 reports
- Endoskeleton™ TCS Interbody System 5210-1063Medtronic Sofamor Danek, Inc. · Awl5 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page