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U.S. Department of Health and Human Services

Class 2 Device Recall ZIMMER UNICOMPARTMENTAL KNEE SYSTEM

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  Class 2 Device Recall ZIMMER UNICOMPARTMENTAL KNEE SYSTEM see related information
Date Initiated by Firm November 29, 2017
Create Date March 14, 2018
Recall Status1 Open3, Classified
Recall Number Z-1055-2018
Recall Event ID 78706
510(K)Number K942263  K880155  
Product Classification Prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer - Product Code HSX
Product FEM PRC LT M/RT L SML
FEM PRC RT M/LT L SML
FEM PRC LT M/RT L SML+
FEM PRC RT M/LT L SML+
FEM PRC LT M/RT L REG
FEM PRC RT M/LT L REG
FEM PRC LT M/RT L REG+
FEM PRC RT M/LT L REG+
FEM PRC LT M/RT L LGE
FEM PRC RT M/LT L LGE
FEM PRC LT M/RT L LGE+
FEM PRC RT M/LT L LGE+

" These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Code Information 00-5790-020-00 00-5790-021-00 00-5790-022-00 00-5790-023-00 00-5790-024-00 00-5790-025-00 00-5790-026-00 00-5790-027-00 00-5790-028-00 00-5790-029-00 00-5790-030-00 00-5790-031-00  00-5790-020-00 61855504 00-5790-020-00 11004267 00-5790-020-00 61933229 00-5790-020-00 61915949 00-5790-020-00 11005144 00-5790-020-00 61949771 00-5790-020-00 62062057 00-5790-020-00 77001776 00-5790-022-00 61788933 00-5790-022-00 61810168 00-5790-022-00 61831670 00-5790-022-00 61894364 00-5790-022-00 11004689 00-5790-022-00 61910487 00-5790-022-00 61932359 00-5790-022-00 11004850 00-5790-022-00 61939861 00-5790-022-00 61958404 00-5790-022-00 61993535 00-5790-022-00 61987879 00-5790-022-00 62041075 00-5790-022-00 62074833 00-5790-022-00 11006797 00-5790-022-00 77001778 00-5790-024-00 61788934 00-5790-024-00 61805631 00-5790-024-00 61822278 00-5790-024-00 61928510 00-5790-024-00 61952565 00-5790-024-00 62025572 00-5790-024-00 62054459 00-5790-024-00 62068114 00-5790-024-00 62080645 00-5790-024-00 62105235 00-5790-024-00 77001780 00-5790-024-00 62110658 00-5790-026-00 61777601 00-5790-026-00 61815430 00-5790-026-00 61824552 00-5790-026-00 61952567 00-5790-026-00 62005615 00-5790-026-00 11006199 00-5790-026-00 62062058 00-5790-026-00 62086067 00-5790-026-00 77001782 00-5790-028-00 61831671 00-5790-028-00 62062059 00-5790-028-00 11006735 00-5790-028-00 77001784 00-5790-030-00 61881087 00-5790-030-00 61968455 00-5790-030-00 77001786 00-5790-021-00 61933230 00-5790-021-00 11005163 00-5790-021-00 11005243 00-5790-021-00 62013359 00-5790-021-00 11006254 00-5790-021-00 62086803 00-5790-021-00 77001777 00-5790-023-00 11003416 00-5790-023-00 61795864 00-5790-023-00 11003680 00-5790-023-00 61810169 00-5790-023-00 11003843 00-5790-023-00 61889207 00-5790-023-00 61904081 00-5790-023-00 61933231 00-5790-023-00 61928509 00-5790-023-00 61949247 00-5790-023-00 61993546 00-5790-023-00 62020300 00-5790-023-00 62056497 00-5790-023-00 62074834 00-5790-023-00 77001779 00-5790-025-00 61777599 00-5790-025-00 61795865 00-5790-025-00 61822279 00-5790-025-00 61899451 00-5790-025-00 61928511 00-5790-025-00 61936678 00-5790-025-00 61952566 00-5790-025-00 11005169 00-5790-025-00 62000808 00-5790-025-00 62020301 00-5790-025-00 62056498 00-5790-025-00 62074835 00-5790-025-00 62080646 00-5790-025-00 11006839 00-5790-025-00 62104129 00-5790-025-00 77001781 00-5790-027-00 61782626 00-5790-027-00 61824553 00-5790-027-00 61921258 00-5790-027-00 61952568 00-5790-027-00 62045723 00-5790-027-00 62068115 00-5790-027-00 62092386 00-5790-027-00 77001783 00-5790-029-00 61805632 00-5790-029-00 62005616 00-5790-029-00 77001785 00-5790-031-00 62002487 00-5790-031-00 77001787 
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin W. Escapule
574-372-4487
Manufacturer Reason
for Recall
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
FDA Determined
Cause 2
Packaging
Action A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action: 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. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 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. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@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 Additi
Quantity in Commerce 13,227 in total
Distribution Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
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 = HSX and Original Applicant = ZIMMER, INC.
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