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 BALL TIP GUIDE WIRE 3.2MMX98CM

  • 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 BALL TIP GUIDE WIRE 3.2MMX98CM see related information
Date Initiated by Firm May 16, 2018
Date Posted June 01, 2018
Recall Status1 Terminated 3 on April 05, 2024
Recall Number Z-2232-2018
Recall Event ID 80193
510(K)Number K831005  
Product Classification Pin, fixation, smooth - Product Code HTY
Product BALL TIP GUIDE WIRE 3.2MMX98CM; 469060

Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Code Information 206660 230706 336160 361630 233262 448180 239047 700990 726170 828140 251680 828150 828100 932260 991350 991420 257058 152610 244850 244840 579040 579060 607290 662730 266560 746130 891170 832130 945420 275658 277507 083000 283676 473260 473270 769460 769470 809470 855610 466680 466700 466690 870170 983590 983770 983780 983600 342490 342560 342580 342590 342600 342610 342620 351370 351360 714680 422590 422610 422640 639830 741180 916630 934020 181790 462670 492510 492520 579490 929360 152000 362310 266540 687720 383870 384390 400980 824370 316600 316610 316630 316620 056630 056640 241130 241120 433960 838690 284980 284990 284960 720780 031840 220850 233970 291970 891450 891460 978430 159640 224200 515930 643890 907460 520050 141150 401760 495360 895470 223120 858380 822490 822500 822510 080760 108480 274700 773730 931830 683150 391810 391820 391830 370500 599560 120420 120430 175580 695660 399290 399300 692960 172710 172730 929090 963120 963130 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-372-3071
Manufacturer Reason
for Recall		 The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2018 on May 16, 2018, to affected consignees via email and FedEx. The letter describes the product, problem and actions to be taken. Consignees were informed of the recall and instructed to take the following actions: Risk Manager Responsibilities: 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. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com b. International returns, please request an IRA by emailing zimmerbiometintlirarequests@zimmerbiomet.com c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall. b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format
Quantity in Commerce 4790
Distribution Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
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 = HTY and Original Applicant = KIRSCHNER MEDICAL CORP.
-
-