Recall record at a glance
| Official record | Z-1510-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Smith & Nephew, Inc. |
| Report date | May 5, 2021 |
| Recall initiation date | Apr 8, 2021 |
| Quantity | 2 units US and 193 units OUS. 195 units WW |
| Location | Andover, MA, United States |
Official product description
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
Why the product was recalled
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Distribution information
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
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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