Percuvance IPN027874

• FDA 510(k) K153063 decided 8 Apr 2016 Active
• FDA GUDID UDI-DI 14026704582850 listed 16 Nov 2017 Listed

• 2 recalls, same reason

  • Terminated Z-0754-2019 FDA Class II ·initiated 3 Jan 2018
  • Terminated Z-0753-2019 FDA Class II ·initiated 3 Jan 2018

  There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

• • Terminated Z-0059-2018 FDA Class II ·initiated 18 Oct 2017

  Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

• 6 recalls, same reason

  • Terminated Z-3222-2017 FDA Class II ·initiated 19 Jul 2017
  • Terminated Z-3219-2017 FDA Class II ·initiated 19 Jul 2017
  • Terminated Z-3221-2017 FDA Class II ·initiated 19 Jul 2017
  • Terminated Z-3224-2017 FDA Class II ·initiated 19 Jul 2017
  • Terminated Z-3220-2017 FDA Class II ·initiated 19 Jul 2017
  • Terminated Z-3223-2017 FDA Class II ·initiated 19 Jul 2017

  For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

1. 19 Jul 2017 Recall initiated FDA recalls Z-3222-2017
2. 19 Jul 2017 Recall initiated FDA recalls Z-3219-2017
3. 19 Jul 2017 Recall initiated FDA recalls Z-3221-2017
4. 19 Jul 2017 Recall initiated FDA recalls Z-3224-2017
5. 19 Jul 2017 Recall initiated FDA recalls Z-3220-2017
6. 19 Jul 2017 Recall initiated FDA recalls Z-3223-2017
7. 18 Oct 2017 Recall initiated FDA recalls Z-0059-2018
8. 16 Nov 2017 Listed FDA GUDID 14026704582850
9. 3 Jan 2018 Recall initiated FDA recalls Z-0754-2019
10. 3 Jan 2018 Recall initiated FDA recalls Z-0753-2019

1 earlier event are in the sections above.

Trade name

Percuvance

Generic name

Laparoscopic blunt dissector

Model / Ref / Catalog

IPN027874, PCVMD5

Primary DI / UDI-DI

14026704582850

510(k) Number

K153063 ↗

FDA product code

GEI

GMDN term

Laparoscopic blunt dissector

Device class

Class II

Regulation number

878.4400

GUDID distribution status

In Commercial Distribution

Size

Width — 0.22 Inch

Length — 3.1 Inch

Category: Laparoscopic blunt dissector

Other devices filed under FDA product code GEI (Electrosurgical, cutting & coagulation & accessories).

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• Arrow IPNB00820 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00826 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00822 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00827 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

See all devices from Teleflex Incorporated →