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U.S. Department of Health and Human Services

Class 2 Device Recall Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS

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  Class 2 Device Recall Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS see related information
Date Initiated by Firm November 04, 2019
Create Date January 03, 2020
Recall Status1 Terminated 3 on May 21, 2021
Recall Number Z-0775-2020
Recall Event ID 84397
510(K)Number K170910  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
Code Information GTIN 07630040712613 REF # Lot 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.24 184524 04.01.24 184524 04.01.24 184524 04.01.25 184525 04.01.25 184525 04.01.25 184525 04.01.26 184526 04.01.26 184526 04.01.26 184526 04.01.27 184527 04.01.27 184527 04.01.27 184527 04.01.27 1901138 04.01.27 1901138 04.01.27 1901138 04.01.27 1901138 04.01.28 184528 04.01.28 184528 04.01.28 1901139 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.30 184530 04.01.30 184530 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.32 184532 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.34 184534 04.01.34 184534 04.01.34 184534 04.01.34 184534 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.40 184540 04.01.40 184540 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.43 184543 04.01.43 184543 04.01.43 184543 04.01.44 184544 04.01.44 184544 04.01.44 184544 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.46 184546 04.01.46 184546 04.01.46 184546 04.01.47 184547 04.01.47 184547 04.01.48 184548 04.01.48 184548 04.01.49 184549 04.01.49 184549 04.01.50 184550 04.01.50 184550 04.01.52 184552 04.01.53 184553 04.01.53 184553 04.01.53 184553 04.01.54 184554 04.01.54 184554 04.01.54 184554 04.01.55 184555 04.01.55 184555    
Recalling Firm/
Manufacturer		 Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information Contact Customer Service
312-878-2381
Manufacturer Reason
for Recall		 Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
FDA Determined
Cause 2		 Device Design
Action On 11/4/19 all distributors with recalled product were immediately notified of the recall by phone. On 11/5/19, all distributors were further notified of the recall via email and requested to return their product to the Memphis warehouse.
Quantity in Commerce 207 units
Distribution US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
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.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = Medacta International SA
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