Recall record at a glance
| Official record | Z-0533-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ethicon, Inc. |
| Report date | Dec 9, 2020 |
| Recall initiation date | Oct 23, 2020 |
| Quantity | 295 units distributed. Only 15 units are being recalled. |
| Location | Somerville, NJ, United States |
Official product description
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Why the product was recalled
The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
Distribution information
The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements.
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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