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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic Salvage System (OSS)

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  Class 2 Device Recall Orthopedic Salvage System (OSS) see related information
Date Initiated by Firm October 10, 2018
Create Date December 07, 2018
Recall Status1 Terminated 3 on April 28, 2020
Recall Number Z-0590-2019
Recall Event ID 81528
510(K)Number K002757  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Code Information 068390
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
Manufacturer Reason
for Recall
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
FDA Determined
Cause 2
Under Investigation by firm
Action On October 10, 2018, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were advised of the product issue. Distributors were asked to take the following actions: 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. If the affected product is located at a hospital, remove the product from the hospital and provide the Risk Manager Recall Notice to the hospital and request that they sign the Certificate of Acknowledgement. 4. Immediately return all affected product from your distributorship and from affected hospitals within your territory along with hospital Certificate of Acknowledgement. a. For each return, 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. 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals included with the email notification sent to your facility. b. Identify whether there are any additional hospitals that Zimmer Biomet is not aware of and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. Hospital Risk Managers were asked to take the following actions: 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
Quantity in Commerce 3 total
Distribution Distributed to accounts in IN, MD, MO, MS, and NM.
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 = KRO and Original Applicant = BIOMET, INC.