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U.S. Department of Health and Human Services

Class 2 Device Recall Acufex Access Advanced Positioning Kit

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  Class 2 Device Recall Acufex Access Advanced Positioning Kit see related information
Date Initiated by Firm December 14, 2021
Create Date February 10, 2022
Recall Status1 Open3, Classified
Recall Number Z-0635-2022
Recall Event ID 89443
Product Classification Component, traction, non-invasive - Product Code KQZ
Product Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures
Product Number: 72205104
Code Information Lot Numbers: 50971615, 50971617 & 50967788
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact SAME
901-396-2121
Manufacturer Reason
for Recall		 Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Smith & Nephew issued Urgent Medical Device (R-2021-11) on 12/14/21 to Hospitals via FedX, to Sales rep. and Foreign Distributor via email.. An updated letter issued 1/14/22 to correct a batch number clerical error. Letters state reason for recall, health risk and action to take: 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 customer s 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. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Quantity in Commerce 271 units
Distribution Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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