Recall record at a glance
| Official record | Z-1910-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Smith & Nephew, Inc. |
| Report date | May 10, 2017 |
| Recall initiation date | Mar 30, 2017 |
| Quantity | 1416 units |
| Location | Memphis, TN, United States |
Official product description
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
Why the product was recalled
The stability data does not support the product labeled with a 10-year shelf life.
Distribution information
Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
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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