Z-2897-2018Class II

Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous...

Name: Z-2897-2018 Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous...
Creator: Richard Wolf GmbH
Published: 2017-07-24
License: https://open.fda.gov/license/

Richard Wolf GmbH / initiated 2017-07-24 / Open, Classified / root cause: manufacturing process

FDA source

Richard Wolf GmbH began a recall of 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... on 2017-07-24. FDA classified it as Class II and gives the reason as "Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2897-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-07-24
Posted: 2018-08-22
Recalling firm: Richard Wolf GmbH
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.
Product code: HRX Arthroscope
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified customers on about 07/24/2018 via a Urgent safety information letter. Customers were instructed to check inventory for the affected device, return the product to Richard Wolf GmbH, and complete and return the response form. The letter also instructed customers to ensure all users in their organization are notified of the recall and to notify customers if the product was further distributed. Safety-related questions can be directed to: Tel.: 0049 7043 35 1013 Questions concerning handling can be directed to: Technical Service Dpt., Tel.: 0049 7043 35 1046
Quantity in commerce: 12 units
Distribution: Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
Product codes and lots: Product Number 89140.0105, Lot Number 4500197481

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2897-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2897-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-22

Product code HRX

K953868Class IIGrasping Forceps, Biopsy Forceps, Scissors, PunchRichard Wolf Medical Instruments Corp. / cleared 1995-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)