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U.S. Department of Health and Human Services

Class 2 Device Recall OSSTM Compress & Mini Compress Anchor Plugs

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  Class 2 Device Recall OSSTM Compress & Mini Compress Anchor Plugs see related information
Date Initiated by Firm October 09, 2023
Date Posted November 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-0373-2024
Recall Event ID 93323
510(K)Number K062998  
Product Classification Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
Product Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178406
Code Information Lot Numbers/UDI 018050 (01)00880304259744(17)270807(10)018050; 018050R (01)00880304259744(17)270807(10)018050R; 056160 (01)00880304259744(17)270108(10)056160; 332030 (01)00880304259744(17)270702(10)332030; 332050 (01)00880304259744(17)270710(10)332050; 608510 (01)00880304259744(17)270924(10)608510; 608600 (01)00880304259744(17)271026(10)608600; 671730 (01)00880304259744(17)270831(10)671730; 752780 (01)00880304259744(17)270817(10)752780;
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
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
FDA Determined
Cause 2
Device Design
Action Zimmer Biomet issued Urgent Medical Device Recall letter on 10/09/23 to Distributors and Risk Managers via email/courier . Letter states reason for recall, health risk and action to take: 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
Distribution Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
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 = KWA and Original Applicant = BIOMET MANUFACTURING CORP.
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