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 Vanguard Anterior Stabilized Tibial Bearing

  • 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 Vanguard Anterior Stabilized Tibial Bearing see related information
Date Initiated by Firm March 13, 2024
Date Posted April 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1607-2024
Recall Event ID 94310
510(K)Number K050222  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a
polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed
into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double
barrier system is placed into a paperboard carton with an IFU and label/indicator dots
applied to the carton.
Code Information Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
FDA Determined
Cause 2		 Process change control
Action On March 27, 2024 URGENT MEDICAL DEVICE RECALL letters were via Email to Distributors and mail to customers. Customers were instructed to: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. This medical device recall was reported to the U.S. Food and Drug Administration and will be reported to other Competent Authorities, Notified Bodies, and Regulatory Authorities as required. ¿ Med Watch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s Med Watch Adverse Event Reporting program either online, by mail, or by fax. ¿ Online: www.fda.gov/medwatch/report.htm ¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm ¿ Fax: 1-800-FDA-0178. Under 21 CFR 803, manufacturers are also required to report any
Quantity in Commerce 19 units (1 US, 18 OUS)
Distribution Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
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 = MBH and Original Applicant = BIOMET, INC.
-
-