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Richard Wolf GmbH · Model 809510205 · UDI-DI 04055207063828

GEY
10
510(k) clearances
18,245
Adverse events
27
Recalls
147
Facilities

Description

CONNECTION CABLE WL 3M For connecting the X1 motor to the 2305 Motor Control Unit, reusable

Recalls

DateFirmReason
2023-02-15Pro-Dex IncBattery 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
2018-09-25Pro-Dex IncVisual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
2017-03-28Aesculap Implant Systems LLCDiamond 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
2017-03-28Aesculap Implant Systems LLCDiamond 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
2017-03-28Aesculap Implant Systems LLCDiamond 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
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.

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Data 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.