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U.S. Department of Health and Human Services

Class 2 Device Recall ENGAGE Cementless Partial Knee System

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  Class 2 Device Recall ENGAGE Cementless Partial Knee System see related information
Date Initiated by Firm May 02, 2023
Date Posted May 31, 2023
Recall Status1 Open3, Classified
Recall Number Z-1672-2023
Recall Event ID 92286
510(K)Number K190439  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Product Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL;
b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL;
c) REF 1-10012-200, SIZE 2-LEFT MEDIAL;
d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL;
e) REF 1-10012-300, SIZE 3-LEFT MEDIAL;
f) REF 1-10012-350, SIZE 3-RIGHT MEDIAL;
g) REF 1-10012-400, SIZE 4-LEFT MEDIAL;
h) REF 1-10012-450, SIZE 4-RIGHT MEDIAL;
i) REF 1-10012-500, SIZE 5-LEFT MEDIAL;
j) REF 1-10012-550, SIZE 5-RIGHT MEDIAL;
k) REF 1-10012-600, SIZE 6-LEFT MEDIAL;
l) REF 1-10012-650, SIZE 6-RIGHT MEDIAL;
Unicondylar knee prothesis
Code Information a) REF 1-10012-100, UDI/DI 00885556873113; b) REF 1-10012-150, UDI/DI 00885556873120; c) REF 1-10012-200, UDI/DI 00885556873137; d) REF 1-10012-250, UDI/DI 00885556873144; e) REF 1-10012-300, UDI/DI 00885556873151; f) REF 1-10012-350, UDI/DI 00885556873168; g) REF 1-10012-400, UDI/DI 00885556873175; h) REF 1-10012-450, UDI/DI 00885556873182; i) REF 1-10012-500, UDI/DI 00885556873199; j) REF 1-10012-550, UDI/DI 00885556873205; k) REF 1-10012-600, UDI/DI 00885556873212; l) REF 1-10012-650, UDI/DI 00885556873229; ALL BATCHES
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-396-2121
Manufacturer Reason
for Recall		 Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
FDA Determined
Cause 2		 Under Investigation by firm
Action Smith & Nephew issued an Urgent Medical Device Recall Notice to its consignees on 05/02/2023 via email and letter. The notice explained the problem and the risk and requested the following: 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, district office, 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 Section A. 2. Please provide a copy of the attached Physician Communication to the surgical staff. The firm is seeking the return of the device.
Quantity in Commerce 2146 units
Distribution US Nationwide distribution.
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 = HSX and Original Applicant = Engage UNI, LLC
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