Home › Richard Wolf GmbH › POWER STICK M5/3
POWER STICK M5/3
Richard Wolf GmbH · Model 8995500031 · UDI-DI 04055207036709
10
510(k) clearances
18,245
Adverse events
27
Recalls
147
Facilities
Description
MOTOR HANDPIECE MAX. 16000RPM with fixed connection cable, for use with rotation tools, with three function buttons, control optional by footswitch, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-15 | Pro-Dex Inc | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch |
| 2018-09-25 | Pro-Dex Inc | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. |
| 2017-03-28 | Aesculap Implant Systems LLC | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m |
| 2017-03-28 | Aesculap Implant Systems LLC | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m |
| 2017-03-28 | Aesculap Implant Systems LLC | Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.