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4.0mm Drill Bit X 160mm
TOBY ORTHOPAEDICS · Model NA · UDI-DI 00816101011193
10
510(k) clearances
17,868
Adverse events (5 deaths)
114
Recalls
557
Facilities
Description
Drill Bits are of various diameters and lengths, and are made of Stainless Steel, heat-treated and passivated. Some drill bits have laser marked scales to show depth of drill.
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.