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U.S. Department of Health and Human Services

Class 2 Device Recall SmithNephew LEGION AP Cutting Block

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  Class 2 Device Recall SmithNephew LEGION AP Cutting Block see related information
Date Initiated by Firm December 16, 2019
Create Date January 28, 2020
Recall Status1 Open3, Classified
Recall Number Z-0878-2020
Recall Event ID 84559
510(K)Number K121393  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product LEGION AP Cutting Block Size 4, REF 71434409;
LEGION AP Cutting Block Size 6, REF 71434411;
LEGION AP Cutting Block Size 7, REF 71434412;
LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
Code Information LEGION AP Cutting Block Size 4, Product Number 71434409, Lot Numbers: 17LM05399, 17LM07852, 17LM07852A; LEGION AP Cutting Block Size 6, Product Number 71434411, Lot Numbers: 17LM05397, 17LM05398, 17LM07849; LEGION AP Cutting Block Size 7, Product Number 71434412, Lot Numbers: 17LM01746, 17LM05390, 17LM05394, 17LM07851; LEGION AP Cutting Block Size 8, Product Number 71434413, Lot Number: 17LM08442.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-749-1440
Manufacturer Reason
for Recall		 Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
FDA Determined
Cause 2		 Process change control
Action The firm initiated the recall by letter on December 16, 2019. The letter identified the problem and directed the consignee to remove the affected lots noted in the Urgent Medical Device Recall Notice.
Quantity in Commerce 59 units
Distribution USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.
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 = MBH and Original Applicant = SMITH & NEPHEW, INC.
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