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 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELFRETAINING/HXC

  • 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 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELFRETAINING/HXCsee related information
Date Initiated by FirmApril 25, 2024
Date PostedMay 28, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1916-2024
Recall Event ID 94546
Product Classification Screwdriver - Product Code HXX
ProductSTARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
Code Information UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactSAME
610-719-6567
Manufacturer Reason
for Recall		Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
FDA Determined
Cause 2		Process change control
ActionDePuy Synthes issued Urgent Medical Device Recall (Removal) Letter on 4/26/24. Letter states reason for recall, health risk and action to take: Examine your inventory to determine if you have the subject product lots and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Sales Consultant or contact the customer support services at ra-dpyuscsspecial@ its.jnj.com to coordinate the return/credits of the subject product lots. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to OneMDField- Actions@its.jnj.com within three (3) business days of receipt of this notification. Please include in the email subject: FA 2363331. 4. Please complete the attached Business Response Form even if you do not have the subject product lots on hand. 5. Forward this notice to anyone in your facility that needs to be informed (e.g., those who manage, transport, store, stock, or use the subject products). 6. If any of the subject product lots have been forwarded to another facility, contact that facility and provide them with this notice. 7. Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
Quantity in Commerce261 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
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.
-
-