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U.S. Department of Health and Human Services

Class 2 Device Recall VERSABOND AB 40 GRAMS FORMULATION 2

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  Class 2 Device Recall VERSABOND AB 40 GRAMS FORMULATION 2 see related information
Date Initiated by Firm December 18, 2020
Create Date January 29, 2021
Recall Status1 Open3, Classified
Recall Number Z-0933-2021
Recall Event ID 87035
510(K)Number K022688  
Product Classification Bone cement - Product Code LOD
Product VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
Code Information Product Number: 71271440; Batch Number: 18LC07540
Recalling Firm/
Manufacturer
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer Reason
for Recall
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
FDA Determined
Cause 2
Storage
Action A Recall notification letter titled, "Urgent Medical Device Recall Notice" was sent to consignees on 12/18/2020 via email and FedEx. The letter instructs the consignee to follow the instructions on the attached response form. The response form provides the following instructions: "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. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com."
Quantity in Commerce 5190 devices
Distribution Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.
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.
510(K) Database 510(K)s with Product Code = LOD and Original Applicant = SMITH & NEPHEW, INC.
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