Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall smith&hephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL see related information
Date Initiated by Firm April 22, 2020
Create Date June 09, 2020
Recall Status1 Open3, Classified
Recall Number Z-2336-2020
Recall Event ID 85637
510(K)Number K070756  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
Product smith&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
Action The 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 Commerce 58 devices
Distribution Worldwide
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 = MBL and Original Applicant = SMITH & NEPHEW, INC.
-
-