Recall record at a glance
| Official record | Z-0458-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ethicon, Inc. |
| Report date | Dec 18, 2013 |
| Recall initiation date | Sep 25, 2013 |
| Quantity | 37,164 eaches |
| Location | Somerville, NJ, United States |
Official product description
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
Why the product was recalled
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Distribution information
Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
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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