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Kit accessori monouso TT Transformer

TT TOOTH TRANSFORMER SRL · Model 01 · UDI-DI 08055728580015

GEY
10
510(k) clearances
18,194
Adverse events
27
Recalls
147
Facilities

Description

Single use kit to be exclusively used with "TT Transformer" medical device to allow its operation.

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.