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 none

  • 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 none see related information
Date Initiated by Firm September 20, 2021
Create Date October 19, 2021
Recall Status1 Terminated 3 on March 24, 2023
Recall Number Z-0143-2022
Recall Event ID 88773
510(K)Number K060736  
Product Classification Screw, fixation, bone - Product Code HWC
Product 6.5MMX165MM CANNULATED SCREW
Code Information Model 71106365S; Lot 20GT39417
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
901-396-2121
Manufacturer Reason
for Recall		 The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
FDA Determined
Cause 2		 Process control
Action Smith & Nephew issued a customer letter via email dated September 20, 2021. Consignees are asked to inspect inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. Consignees must complete the enclosed response form, sign and send to FieldActions@smith-nephew.com. Response form shall be completed even if there is no impacted product on hand.
Quantity in Commerce 5 units
Distribution Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
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 = HWC and Original Applicant = SMITH & NEPHEW, INC.
-
-