AMP 117-165Recalls & reported problems
Alphatec Spine, Inc. · LIF AMP, Adjustable Awl · Class 1
All models of AMP (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Jul 7, 2023Open, Classified
Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
Z-2475-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other AWL devices
- Meridian RA2-003015Seaspine Orthopedics Corporation · AWL1 recall1 report
- SYNFIX Evolution 03.835.032Synthes GmbH · AWL16 reports
- NA 359.213Synthes GmbH · AWL7 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · AWL7 reports
- NA 03.820.100Synthes GmbH · AWL6 reports
- Endoskeleton™ TCS Interbody System 5210-1063Medtronic Sofamor Danek, Inc. · Awl5 reports
- NA 03.010.040Synthes GmbH · AWL4 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 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