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U.S. Department of Health and Human Services

Class 2 Device Recall GENDER SOLUTIONS NATURALKNEE FLEX SYSTEM

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  Class 2 Device Recall GENDER SOLUTIONS NATURALKNEE FLEX SYSTEM see related information
Date Initiated by Firm November 29, 2017
Create Date March 14, 2018
Recall Status1 Open3, Classified
Recall Number Z-1060-2018
Recall Event ID 78706
510(K)Number K071107  K070214  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿
N-K FLX GSF NP FEM SZ 0 RT
N-K FLX GSF NP FEM SZ 4 LT
N-K FLX GSF NP FEM SZ 4 RT

Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
Code Information 00-5414-013-02 61768287 00-5414-013-02 61768287R 00-5414-013-02 77001023 00-5414-013-02 61871391 00-5414-013-02 61876203 00-5414-013-02 61889334 00-5414-013-02 61910523 00-5414-013-02 61940029 00-5414-013-02 61971424 00-5414-013-02 61983528 00-5414-013-02 61994980 00-5414-013-02 62001882 00-5414-013-02 62020365 00-5414-013-02 62032695 00-5414-013-02 11006436 00-5414-013-02 62046201 00-5414-013-02 62054637 00-5414-013-02 62054637R 00-5414-013-02 62074928 00-5414-013-02 62094873 00-5414-013-02 62103499 00-5414-013-02 62117187 00-5414-013-02 62128275 00-5414-017-01 61777741 00-5414-017-01 61801560 00-5414-017-01 77001027 00-5414-017-01 61837057 00-5414-017-01 61867209 00-5414-017-01 61885276 00-5414-017-01 61889362 00-5414-017-01 61872013 00-5414-017-01 61904178 00-5414-017-01 61904178R 00-5414-017-01 61910561 00-5414-017-01 11004925 00-5414-017-01 61928674 00-5414-017-01 61952632 00-5414-017-01 61963823 00-5414-017-01 61971475 00-5414-017-01 61988083 00-5414-017-01 61994991 00-5414-017-01 62005770 00-5414-017-01 77001464 00-5414-017-01 62025843 00-5414-017-01 62041147 00-5414-017-01 62054638 00-5414-017-01 11006490 00-5414-017-01 62062144 00-5414-017-01 62074934 00-5414-017-01 62094875 00-5414-017-01 62117197 00-5414-017-02 61774297 00-5414-017-02 61824684 00-5414-017-02 61871418 00-5414-017-02 61876224 00-5414-017-02 61889363 00-5414-017-02 61899535 00-5414-017-02 61904179 00-5414-017-02 61933394 00-5414-017-02 61950165 00-5414-017-02 61928675 00-5414-017-02 61950166 00-5414-017-02 61952633 00-5414-017-02 61950164 00-5414-017-02 11005236 00-5414-017-02 11005311 00-5414-017-02 61958472 00-5414-017-02 61994989 00-5414-017-02 62001895 00-5414-017-02 62005771 00-5414-017-02 62025844 00-5414-017-02 62054634 00-5414-017-02 62046213 00-5414-017-02 62062145 00-5414-017-02 62074937 00-5414-017-02 11006896 00-5414-017-02 62104630 00-5414-017-02 62110727 
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 = JWH and Original Applicant = ZIMMER, INC.
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