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 Biomet

  • 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 Biometsee related information
Date Initiated by FirmOctober 24, 2018
Create DateDecember 04, 2018
Recall Status1 Terminated 3 on April 14, 2020
Recall NumberZ-0553-2019
Recall Event ID 81513
510(K)NumberK062998 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductBiomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) components are intended for uncemented use only.
Code Information Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740
FEI Number 1825034
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
FDA Determined
Cause 2		Employee error
ActionZimmer Biomet initiated recall by letter on 10/24/18 to distributors and hospitals advising of the problem and action to be taken-locate quarantine and return product. Complete Inventory Return Certification Form. Questions or concerns call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in Commerce6 units
DistributionUS Nationwide Distribution in the states of IN, DC, MD
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JDI
-
-