Recall Z-2897-2018— Richard Wolf GmbH

Name: FDA recall Z-2897-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-24

Class II · Ongoing

Class II FDA medical device recall by Richard Wolf GmbH, initiated 2017-07-24. It names one FDA 510(k) clearance: K953868. Product: Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.. Reason: Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury..

Recalling firm: Richard Wolf GmbH
Classification: Class II
Status: Ongoing
Initiated: 2017-07-24
Firm location: Knittlingen, Germany

510(k) clearances named in this recall

1 on FDA's record

K953868 — GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCHRichard Wolf Medical Instruments Corp.·cleared 1995-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.

Reason for recall

Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.