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 A.L.P.S. Clavicle Plating System

  • 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 A.L.P.S. Clavicle Plating System see related information
Date Initiated by Firm December 23, 2020
Date Posted January 21, 2021
Recall Status1 Terminated 3 on April 13, 2023
Recall Number Z-0882-2021
Recall Event ID 87095
510(K)Number K173767  
Product Classification Plate, fixation, bone - Product Code HRS
Product A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Code Information Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-372-1687
Manufacturer Reason
for Recall		 The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
FDA Determined
Cause 2		 Device Design
Action On 12/30/2020, Zimmer Biomet issued an Urgent Medical Device Recall to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors will be notified via email. Hospital risk managers and surgeons, as well as distributors with product, will be notified via courier.
Quantity in Commerce 174 systems
Distribution Nationwide distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = Biomet Inc.
-
-