FDA Medical Device Recalls (openFDA)
Richard Wolf GmbH: 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.
- Recall number
- Z-2897-2018
- 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.
- Status
- Open, Classified
- Initiated
- 2017-07-24
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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
- 12 units
- Distribution
- Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
- Lot, serial or model codes
- Product Number 89140.0105, Lot Number 4500197481
- 510(k) numbers
- ["K953868"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3002808001
- Firm city
- Knittlingen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28