CLASS II ONGOING Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
Artholine Punch B 4 H 1, used recalled by Richard Wolf
Richard Wolf is recalling Artholine Punch B 4 H 1, used for the removal of soft tissue, cartilage tissue or other. The recall was initiated on 24 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2897-2018
- FDA event ID
- 80583
- Recalling firm
- Richard Wolf, Knittlingen
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2017
- FDA classified
- 22 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 24 Jul 2017 | Recall initiated by company | |
| 22 Aug 2018 | Classified by FDA | +394 days |
| 29 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
Questions about this recall
Is Artholine Punch B 4 H 1, used for the removal of soft tissue, cartilage tissue or other recalled?
Yes. Richard Wolf recalled Artholine Punch B 4 H 1, used for the removal of soft tissue, cartilage tissue or other on 24 Jul 2017. The recall is Class II and its status is Ongoing. Recall number Z-2897-2018.
Why was it recalled?
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
Which lots are affected?
Product Number 89140.0105, Lot Number 4500197481
Where was it sold?
Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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