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WAW HYBRID TORNADO Schambach PUNCH 1.00

Devroye Instruments Belgium · Model 1.00LH2508 · UDI-DI 05430003362075

GEY Prescription

510(k) clearances

18,328

Adverse events

Recalls

147

Facilities

Description

The WAW Hybrid Tornado Punch is a single use medical device intended to prepare follicular units for extraction from a patient's body, as part of a hair transplantation procedure. This is done by coring the tissues included in the hair follicle to separate them from the surrounding tissues. The movement of the WAW Hybrid Tornado Punch is intended to be provided by its accessory, the WAW Duo FUE System active device. The punch is intended to be used with the WAW Duo FUE System. More specifically, the punch is intended to be mounted on the handpiece of the system. It is inserted in the handpiece extremity during the FUE procedure. The punch is compatible with both handpieces of the system (wired and wireless). The device is invasive and sterilizable (autoclave), but not reusable. The device is intended to be sterilized by the user before use. A maximum of two devices can be used during a single procedure. The WAW Hybrid Tornado Punch is available in 8 different diameters ranging from 0.8 to 1.2 mm. The choice of punch depends on the number of hairs per graft, the thickness of the hairs and how close they are to each other. Additionally, the Hybrid Tornado Schambach Notches Punch is an extra model with 4 notches on the toothed part specifically designed for extracting long hair (Long Hair FUE). It comes in a single diameter of 1.0 mm, in two different materials (two different types of stainless steel).

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.

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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.