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Helix Classic Reamers
Dentatus AB · Model RSA-456 · UDI-DI 07350081491925
10
510(k) clearances
599
Adverse events
3
Recalls
190
Facilities
Description
3x Assorted Helix Classic Reamers - Sizes #4 to #6 Short (1 of each size)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-14 | Straumann USA LLC | The referred batch was produced without the laser engraving of 7 mm. |
| 2017-07-10 | Zimmer Dental Inc | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the produc |
| 2009-06-29 | Biomet 3i, LLC | Some of the packages of ACT3020, drills may actually contain an ACT3220 drill. |
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