Lower riskMedical device recall · FDA · Published April 8, 2021
Smith & Nephew CANNU-Flex SILK Screws: Mislabeled Size Risk
Smith & Neph: Recall of 6mm x 30mm interference screws due to mislabeled box containing 6mm x 20mm screws. Affected users should check product details.
“Smith & Nephew CANNU-Flex SILK Screws: Mislabeled Size Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62820-smith-nephew-cannu-flex-silk-screws-mislabeled-size-risk. Based on FDA recall #Z-1510-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2021%22&limit=1).
Smith & Nephew, Inc. recalled CANNU-Flex SILK Interference Screws 6 mmx 30 mm on April 8, 2021, after the FDA announced that mislabeled boxes contained incorrect screw sizes. The Food and Drug Administration issued the voluntary Class II recall due to labeling errors.
How to tell if you have it
Brand: Smith & Nephew
Product: CANNU-Flex SILK Interference Screws 6 mmx 30 mm
Part Number: 014208
Lot Number: 50906647
The hazard
The FDA stated that the mislabeled box contained a 6mm x 20mm screw instead of the intended 6mm x 30mm screw. The product is used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction.
Context
GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls on record since July 24, 2017. Other recent recalls of similar products include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and the Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include the Tornier Perip Screw Recall (Dec. 19, 2025), the XTANT Medical Xpress Pedicle Screw System recall (Feb. 18, 2026), and the APTUS 2.8 TriLock Screw Recall (Jan. 9, 2026).
How to tell if you have this one
Check the box for a part number of 014208 and lot number 50906647. The screws are used for anterior cruciate ligament reconstruction procedures.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for part number 014208 and lot number 50906647 on the box.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1510-2021 (April 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1510-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.