Reported Jun 4, 2025 · Ongoing
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code:…
Prismatik Dentalcraft, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Prismatik Dentalcraft, Inc. · 2144 Michelson Dr · Irvine, CA · 92612-1304
Is this the product you have?
- Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266
- UDI code+D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel
- Lot codes and dates
- Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266
- UDI code+D7457071SRG02660/$$76254798/16D20250219V
- Lot Number6254798
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
This product could cause temporary or reversible health problems — stop using it.
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