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Brasseler USA
Peter Brasseler Holdings, LLC · Model BR10-001 · UDI-DI 00887919971733
10
510(k) clearances
1,087
Adverse events
6
Recalls
63
Facilities
Description
BR10-001 VersaDriver Pnuematic Handpiece
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2014-05-08 | The Anspach Effort, Inc. | Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DF |
| 2013-04-25 | The Anspach Effort, Inc. | The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pre |
| 2011-05-06 | The Anspach Effort, Inc. | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog |
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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.