Data Foundry

Medical device recalls 2018

Artholine Punch B 4 — Class II medical device recall Z-2897-2018

Ongoing recall by Richard Wolf GmbH, reported 2018-08-29. Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential f

Recall numberZ-2897-2018
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRichard Wolf GmbH, Knittlingen, Germany
Recall initiated2017-07-24
Classified2018-08-22
Reported by FDA2018-08-29
Countries outside the USDE, HK, IE, RO, TR
Quantity12 units
Lot numbers4500197481

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2897-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.