Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1510-2021 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeMAI
Date Initiated2021-04-08
Date Terminated2022-06-22
Product Quantity2 units US and 193 units OUS. 195 units WW

Reason for Recall

Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw

Firm Action

Smith & Nephew issued Urgent Medical Device Recall letter FSN on April 08, 2021via email and FedEx. Letter states reason for recall, health risk and action to take: Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected]. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑