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U.S. Department of Health and Human Services

Class 2 Device Recall various polyethylene implants Custom parts

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  Class 2 Device Recall various polyethylene implants Custom parts 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-1862-2017
Recall Event ID 76507
Product Classification unknown device name - Product Code N/A
Product various polyethylene implants
Custom parts

Product Usage:
Code Information Items and lots:, Item 110010452, 732130, 920720, Item 110010454, 136510, Item 110010455, 752320, 896040, Item 110010456, 383320, 879930, Item 110010459, 854290, 879950, 905350, Item 110010462, 752460, 778490, Item 110010468, 827730, Item 110010476, 827530, 827540, Item 110010716, 753050, ItemCP753453, 655990, ItemCP753455, 656110, ItemCP753461, 382210, Item CP753470, 436530, Item CP753476, 502920, Item CP753478, 524950, Item CP753480, 436460, Item CP753486, 655300, Item CP753488, 655470, Item CP753494, 467390, Item CP753496, 467420, Item CP753502, 448730, Item CP753504, 453990, Item CP753506, 454640, Item CP753508, 502970, Item CP753510, 831310, Item CP753512, 654720, Item CP753514, 594570, Item CP753517, 594630, Item CP753519, 534820, Item CP753521, 535090, Item CP753523, 654190, Item CP753525, 674160, Item CP753531, 691490, Item CP753533, 691560, Item CP753535, 691640, Item CP753537, 691680, Item CP753547, 691720, Item CP753549, 696620.
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
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

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.