Recall record at a glance
| Official record | Z-2897-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Richard Wolf GmbH |
| Report date | Aug 29, 2018 |
| Recall initiation date | Jul 24, 2017 |
| Quantity | 12 units |
| Location | Knittlingen, Germany |
Official 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.
Why the product was 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.
Distribution information
Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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