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U.S. Department of Health and Human Services

Class 2 Device Recall various polyethylene implants

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  Class 2 Device Recall various polyethylene implants see related information
Date Initiated by Firm February 17, 2017
Date Posted March 27, 2017
Recall Status1 Open3, Classified
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 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 = JDI and Original Applicant = BIOMET ORTHOPEDICS, INC.
510(K)s with Product Code = JDI and Original Applicant = BIOMET, INC.
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