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 INTEGRA SURFIX ALPHA Screwdriver Torx 10

  • 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 INTEGRA SURFIX ALPHA Screwdriver Torx 10 see related information
Date Initiated by Firm January 04, 2022
Create Date February 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-0548-2022
Recall Event ID 89382
510(K)Number K073375  
Product Classification Plate, fixation, bone - Product Code HRS
Product INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Code Information UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Dave Sunder
978-749-1440
Manufacturer Reason
for Recall		 The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.
Quantity in Commerce 8 units (US)
Distribution US Nationwide distribution in the states of CA and OH.
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 = HRS and Original Applicant = NEWDEAL SAS
-
-