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 various polyethylene implants

  • 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 various polyethylene implants see related information
Date Initiated by Firm February 17, 2017
Date Posted March 27, 2017
Recall Status1 Terminated 3 on January 29, 2018
Recall Number Z-1860-2017
Recall Event ID 76507
510(K)Number K023357  K032396  K042051  K051569  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product various polyethylene implants
Hips
Active Articulation ArComXL Bearings
Active Articulation E1 Bearings
Arcos Taper Cap
BIOLOX delta Option Head
E1 RingLoc Bi-Polar
Freedom Constrained Liner +5mm
Hi-Wall ArcomXL All Poly
Rimloc E1 10 Degree Liner
RingLoc +3mm Hi-Wall E1 Liner
Ringloc +3mm Neutral Max-Rom ArComXL Liner
Ringloc +3mm Neutral Max-Rom E1 Liner
Ringloc +5mm Neutral Max-Rom E1 Liner
Ringloc 10 Degree ArCom Liner
Ringloc 10 Degree Face Changing ArComXL Liner
Ringloc 10 Degree Face Changing E1 Liner
RingLoc Bi-Polar
Ringloc Hi-Wall ArCom Liner
RingLoc Hi-Wall ArComXL Liner
RingLoc Hi-Wall E1 Liner
Ringloc Neutral Max-Rom ArCom Liner
RingLoc Neutral Max-Rom ArComXL Liner
RingLoc Neutral Max-Rom E1 Liner


Product Usage:
For use in hip arthroplasty
Code Information Items and lots: Item 11-105900 712480 Item 11-105901 695030 695040 Item 11-105902 309540 605110 605120 605130 712810 712830 712850 712860 Item 11-105911 577890 Item 11-105912 577920 Item 11-105913 577930 Item 11-105933 577950 Item 11-165208 779480 797810 Item 11-165216 905190 Item 11-165220 905230 Item 11-165222 808510 905270 920560 Item 11-165224 905130 Item 11-165226 758530 758550 797970 920600 Item 11-165228 879860 Item 11-165232 716050 732560 732580 920670 Item 11-165236 896290 Item 11-165240 779430 Item 12-105994 272230 Item CP162598 354160 Item EP-105833 371770 Item EP-105882 604860 Item EP-105894 371780 667310 Item EP-105914 371640 443510 443520 667250 667260 Item EP-105916 455050 577290 Item EP-105917 577300 Item EP-105918 577250 Item EP-105923 455070 577320 577340 728050 728080 728150 728180 Item EP-105925 577380 Item EP-105926 577390 Item EP-105933 455080 577360 Item EP-105934 604870 Item EP-105996 577420 Item EP-107926 811990 Item EP-108223 275040 Item EP-108322 371730 Item EP-108323 371740 667290 667300 Item EP-108424 272270 455100 Item EP-108425 455110 Item EP-108524 455120 Item EP-108525 240900 Item EP-176238 602380 Item EP-200144 455130 455150 728200 728220 Item EP-200146 390550 577450 577460 577480 Item EP-200148 511810 511820 511830 511840 511880 728230 728240 Item EP-200150 455180 455190 511890 511900 511910 728250 728270 Item EP-200152 455200 728300 728320 728340 Item EP-200154 455210 Item EP-200156 577490 577500 Item EP-200158 577510 577520 ItemEP-200160 455220 Item XL-105833 542210 542220 542230 542240 Item XL-105834 542250 Item XL-105835 614420 Item XL-105884 604960 Item XL-105885 588450 Item XL-105903 502330 502340 Item XL-105905 588490 Item XL-105914 502370 502380 Item XL-105923 290100 502390 502410 779270 Item XL-105924 309510 502430 502440 779340 Item XL-105925 502450 Item XL-105933 309520 502460 605000 779590 Item XL-105934 290110 502490 Item XL-105994 309530 Item XL-108222 290120 Item XL-108223 605040 Item XL-200144 605050 Item XL-200146 502590 644000 Item XL-200148 290130 502600 502610 Item XL-200150 502620 502630 Item XL-200152 502640 Item XL-200154 290140 Item XL-200158 502650 Item XL-200160 644030 Item XL-222846 290150 Item XL-223248 290160 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
800-348-2759
Manufacturer Reason
for Recall		 Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
FDA Determined
Cause 2		 Process design
Action On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Clearly mark RECALL on the outside of return boxes. 5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
Quantity in Commerce 28,253 in total
Distribution Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
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 = JDI and Original Applicant = BIOMET ORTHOPEDICS, INC.
510(K)s with Product Code = JDI and Original Applicant = BIOMET, INC.
-
-