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U.S. Department of Health and Human Services

Class 2 Device Recall BlockAid Gloves

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  Class 2 Device Recall BlockAid Gloves see related information
Date Initiated by Firm September 11, 2017
Date Posted February 01, 2018
Recall Status1 Terminated 3 on August 30, 2018
Recall Number Z-0609-2018
Recall Event ID 79082
510(K)Number K902633  
Product Classification Accessory, surgical apparel - Product Code LYU
Product BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131
Code Information Item Number Lot Number Expiration Date: 1. 650126 326624 9/30/2017; 2. 650126 330363 11/30/2017; 3. 650128 330363 12/1/2017; 4. 650129 330363 12/1/2017; 5. 650129 351411 6/28/2018; 6. 650127 353495 7/28/2018; 7. 650128 353498 7/28/2018; 8. 650131 353504 7/28/2018; 9. 650129 357204 7/28/2018; 10. 650128 361436 8/28/2018; 11. 650129 361467 8/28/2018; 12. 650128 000011 11/28/2018; 13. 650128 231984 12/22/2018; 14. 650129 000011 2/28/2019; 15. 650128 379203 2/28/2019; 16. 650131 390179 6/28/2019; 17. 650131 395315 8/28/2019; 18. 650128 259231 9/30/2019; 19. 650127 401155 10/28/2019; 20. 650130 402602 10/28/2019; 21. 650127 402602 11/28/2019; 22. 650131 402602 11/28/2019; 23. 650128 393754 12/28/2019; 24. 650129 402602 1/28/2020; 25. 650130 417501 9/28/2020; 26. 650128 437240 11/28/2020; 27. 650127 437240 12/28/2020; 28. 650130 437240 12/28/2020; 29. 650129 437240 1/28/2021; 30. 650128 444717 4/28/2021; 31. 650129 444717 4/28/2021; 32. 650131 457763 4/28/2021; 33. 650128 457130 6/28/2021; 34. 650130 457130 6/28/2021; 35. 650129 457130 8/28/2021; 36. 650130 476615 1/28/2022; 37. 650130 486487 3/28/2022; 38. 650129 486488 3/28/2022; 39. 650130 482368 4/28/2022; 40. 650127 482370 4/28/2022; 41. 650129 482370 4/28/2022; 42. 650130 343401 4/30/2018  
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Kevin W. Escapule
574-372-4487
Manufacturer Reason
for Recall		 Cut resistant surgical glove liners lack sterility assurance.
FDA Determined
Cause 2		 Process control
Action 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.
Quantity in Commerce 1863
Distribution Distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV and Washington, DC. Distributed to 1 Veteran's Administration hospital in MO. Distributed in Netherland, Peru, and Switzerland.
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 = LYU and Original Applicant = BIOMET, INC.
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