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U.S. Department of Health and Human Services

Class 2 Device Recall Reusable Cannula

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  Class 2 Device Recall Reusable Cannula see related information
Date Initiated by Firm September 21, 2020
Create Date October 27, 2020
Recall Status1 Terminated 3 on March 22, 2024
Recall Number Z-0301-2021
Recall Event ID 86502
Product Classification Accessories, arthroscopic - Product Code NBH
Product 5.5MM Arthrogarde Hip Access Cannula
Code Information Model: 72201743, Lot: 50838788, 50834909,50846565, 50842905 & 50822169.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
150 Minuteman Rd
Andover MA 01810-1031
Manufacturer Reason
for Recall		 The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
FDA Determined
Cause 2		 Process control
Action On 9/21/2020 the firm send a notification to its consignees with the following instructions: Required Actions: 1. 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 FieldActions@smith-nephew.com. 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.
Quantity in Commerce 143 units
Distribution Domestic Distribution: CA, CO, CT, GA, IA, IL, IN, MD, MO, NC, NY, OH, PA, SC, TN, TX, WA, WI, WV. International Distribution: AU, BR, CA, CL, CN, CO, DE, ES, GB, HK, KR, PA, PT, TW.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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