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U.S. Department of Health and Human Services

Class 2 Device Recall smith&hephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL

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 Class 2 Device Recall smith&hephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELLsee related information
Date Initiated by FirmApril 22, 2020
Create DateJune 09, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2336-2020
Recall Event ID 85637
510(K)NumberK070756 
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
Productsmith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.
Code Information 71338733, Lot Numbers: 19DM28110, 19DM28106, 19DM28106A  71338734, Lot Numbers: 19DM28114  71338735, Lot Numbers: 19DM28116  71338736, Lot Numbers: 19EM19673, 19EM19683, 19EM19678  71338737, Lot Numbers: 18JM12872  71338738, Lot Numbers: 18FM02387  71338740, Lot Numbers: 18JM02713  71338741, Lot Numbers: 19AM22770, 19AM22770A
Recalling Firm/
Manufacturer
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
Manufacturer Reason
for Recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
FDA Determined
Cause 2
Process control
ActionThe firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com.
Quantity in Commerce58 devices
DistributionWorldwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MBL
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