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Integra®
Ascension Orthopedics, Inc. · Model 12224027 · UDI-DI 10381780237709
HTW
Prescription
10
510(k) clearances
17,868
Adverse events (5 deaths)
114
Recalls
557
Facilities
Description
The drill is used in conjunction with the half pins for the Integra External Fixation System.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-11 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de |
| 2026-02-11 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de |
| 2024-01-29 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of |
| 2024-01-29 | Waldemar Link GmbH & Co. KG (Mfg Site) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-09-01 | Flower Orthopedics Corporation | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| 2021-07-30 | Paragon 28, Inc. | A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath. |
| 2021-02-24 | Arthrex, Inc. | The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. |
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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.