| Class 2 Device Recall smith&hephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MBL
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