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U.S. Department of Health and Human Services

Class 2 Device Recall ANTHOLOGY POROUS HIGH OFFSET STEM

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  Class 2 Device Recall ANTHOLOGY POROUS HIGH OFFSET STEM see related information
Date Initiated by Firm May 02, 2018
Date Posted May 09, 2018
Recall Status1 Terminated 3 on September 01, 2020
Recall Number Z-1921-2018
Recall Event ID 80050
510(K)Number K052792  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Code Information Lot Numbers: 17LM22019, 17LM10934, 17LM05900
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
978-749-1440
Manufacturer Reason
for Recall		 Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter on 05/02/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440
Quantity in Commerce 13 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 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 = JDI and Original Applicant = SMITH & NEPHEW, INC.
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